GMP Cannabis

Recommendations to Regulators:
Cannabis Manufacturing, Packaging,

Labeling, and Holding Operations
July 2014
The legal status of Cannabis spp. products is in a transitional phase in many states in
the United States. Where products that contain articles consisting of or derived from
Cannabis were formally illegal throughout the U.S., many state laws now allow adult use
of these either for medical purposes only or for any social adult use.
The American Herbal Products Association (AHPA) chartered a Cannabis Committee in

2010 with an express purpose to address issues related to the safe use and responsible
commerce of legally-marketed products derived from Cannabis species.
To meet its purpose the AHPA Cannabis Committee is in the process of developing
recommendations to regulators for best practice rules to address four operational
stages of Cannabis production and distribution: cultivation; manufacturing and related
operations; laboratory practice; and dispensing.
The present document provides recommendations to regulators in the specific area of
Cannabis Manufacturing, Packaging, Labeling and Holding Operations, and is
presented in the form of a draft regulation. These recommendations are intended to
establish a basis for oversight of entities that are engaged in any of these operations
with regard to Cannabis and Cannabis-derived products. These recommendations are
modeled generally after federal current good manufacturing practice for foods and
dietary supplements, and focus on personnel, product acquisition, plants and grounds,
relevant controls, recordkeeping, and other matters that can contribute to best practice
in these operational settings.
The AHPA Cannabis Committee offers this document to states and local municipalities
where use of Cannabis and Cannabis-derived products is allowed under local law such
that regulatory authorities can consider the adoption of these recommendations, in
whole or in part, as the basis for development of jurisdiction-specific regulations.
Please contact AHPA for further information or to discuss this document further.
Point of contacts:
Michael McGuffin / P: 301-588-1171 x201 / E: mmcguffin@ahpa.org
Jane Wilson / P: 734-476-9690 / E: jwilson@ahpa.org
PART [X] – Cannabis manufacturing, packaging, labeling and
holding operations
Subpart A – General provisions ................................................................................... 3

Section 1.1 Subject operations ............................................................................... 3
Section 1.2 Other statutory provisions and regulations .......................................... 3
Section 1.3 Definitions ............................................................................................ 3
Subpart B – General requirements .............................................................................. 8
Section 2.1 Acquisition of cannabis and cannabis-derived products ...................... 9
Section 2.2 Distribution of cannabis and cannabis-derived products ..................... 9
Section 2.3 Ancillary operations ............................................................................. 9
Subpart C – Personnel ................................................................................................. 9
Section 3.1 Personnel training.............................................................................. 10
Section 3.2 Personnel responsibilities .................................................................. 10
Section 3.3 Personnel safety ................................................................................ 12
Section 3.4 Supervisor requirements ................................................................... 12
Subpart D – Physical plant and grounds .................................................................... 13
Section 4.1 Design and construction .................................................................... 13
Section 4.2 Sanitation requirements ..................................................................... 16
Section 4.3 Equipment and utensils ..................................................................... 19
Section 4.4 Security requirements........................................................................ 22
Subpart E – Manufacturing process controls ............................................................. 22
Section 5.1 Manufacturing protocol ...................................................................... 22
Section 5.2 Manufacturing component control requirements................................ 23
Section 5.3 Manufacturing batch record ............................................................... 25
Section 5.4 Allocation and charge-in of components ............................................ 26
Section 5.5 Process monitoring and controls during manufacturing ..................... 27
Section 5.6 Manufacturing sampling requirements............................................... 28
Section 5.7 Cannabis-derived product specifications ........................................... 31
Section 5.8 In-process material specifications, sampling, and testing .................. 32
FOR DISCUSSION. Prepared for consideration by state or local regulatory

agencies in states within the United States.
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Section 5.9 Calculation of yield ............................................................................ 33
Subpart F – Packaging and labeling process controls ............................................... 33
Section 6.1 General considerations for packaging components, including labels 33
Section 6.2 Packaging and/or labeling protocol.................................................... 35
Section 6.3 Packaging and/or labeling batch record ............................................ 36
Section 6.4 Label content for cannabis and cannabis-derived products............... 38
Subpart G – Holding controls ..................................................................................... 39
Section 7.1 Identification ...................................................................................... 39
Section 7.2 Storage and handling ........................................................................ 40
Section 7.3 Withholding materials from use or distribution ................................... 40
Subpart H – Inventory and recordkeeping.................................................................. 41
Section 8.1 Materials inventory ............................................................................ 41
Section 8.2 Distributed materials .......................................................................... 43
Section 8.4 Reconciliation .................................................................................... 44
Section 8.5 Record retention ................................................................................ 44
Subpart I – Complaints, returns, and recalls .............................................................. 45
Section 9.1 Complaint files ................................................................................... 45
Section 9.2 Returned products ............................................................................. 46
Section 9.3 Recall procedures.............................................................................. 47

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SUBPART A – GENERAL PROVISIONS
Section 1.1 Subject operations

(a) Except as provided by paragraphs (b), (c), and (d) of this section, any person, group
of persons, non-profit entity, or business entity is subject to this part if engaged in
manufacturing, packaging, labeling, or holding operations for cannabis or cannabis-
derived products in the jurisdiction in which this part applies1, 2.
(b) A compliant individual that manufactures, packs, labels or holds cannabis or
cannabis-derived products in accordance with local and state law for personal use;
or for another compliant individual at no charge, is not subject to this part.
(c) Cultivation and processing operations are not subject to this part; however, this
exemption does not apply to any off-site warehouse or storage facility that serves
the cultivation or processing operation.
(d) Dispensing operations are not subject to this part; however, this exemption does not
apply to any off-site warehouse or storage facility that serves the dispensing
operation.
(e) Each operation subject to this part is responsible to comply with only those sections
that apply to the activities conducted by that operation.
Section 1.2 Other statutory provisions and regulations

In addition to this part, manufacturing, packaging, labeling and holding operations must
comply with all other applicable statutory provisions and regulations related to these
operations in the jurisdiction in which this part applies, and related to all other business
activities undertaken in conducting these operations.
Section 1.3 Definitions

The following definitions apply to this part:
Actual yield means the quantity that is actually produced at any appropriate step of
manufacture or packaging of a particular cannabis-derived product.
1
This term “in the jurisdiction where this part applies” may be replaced throughout with the name of the
specific jurisdiction.
2
These requirements are intended to apply to subject operations having multiple personnel and that
manufacture, package, label, or hold some hundreds of ounces (thousands of grams) of cannabis per
year for commercial purposes rather than personal use. State and local jurisdictions may consider this
limitation in determining applicability of these requirements to subject operations.

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Adulteration means that a cannabis-derived product (1) consists in whole or in part of
any filthy, putrid, or decomposed substance; or (2) bears or contains any poisonous or
deleterious substance which may render it injurious to health; except that (A) such
product shall not be considered adulterated if the quantity of such substance does not
ordinarily render it injurious to health and (B) the cannabis content of the product shall
not be considered injurious to health; (3)(A) has been manufactured, packaged, labeled,
or held under insanitary conditions whereby it may have become contaminated with filth,
or whereby it may have been rendered injurious to health; or (B) has been
manufactured, packaged, labeled, or held by methods, in facilities, or using controls that
do not conform to or are not operated or administered in conformity with this part to
assure that the cannabis-derived product meets appropriate requirements as to safety;
or (4) fails to meet appropriate requirements as to safety; or (5) is in a container
composed, in whole or in part, of any poisonous or deleterious substance which may
render the contents injurious to health; or (6) bears or contains, for purposes of coloring,
a color additive which is not approved in the United States for use in a comparable food
product; or (7) (A) has been mixed or packaged with any substance so as to reduce its
quality or strength or (B) has been substituted wholly or in part with any substance.
Batch means, with regard to cannabis, a specific quantity of cannabis harvested during
a specified time period from a specified cultivation area; and means, with regard to
cannabis-derived product, a specific quantity that is uniform, that is intended to meet
specifications for identity, strength, purity and composition, and that is manufactured,
packaged and/or labeled during a specified time period according to a single
manufacturing, packaging, and/or labeling batch record.
Batch number, lot number, or control number means any distinctive group of letters,
numbers, or symbols, or any combination of them, from which the complete history of
the manufacturing, packaging, labeling, or holding of a batch or lot of cannabis or
cannabis-derived products can be determined.
Cannabis means any of the aerial parts of a plant in the genus Cannabis, and does not
mean hemp.
Cannabis-derived product means a product, other than cannabis itself, which contains
or is derived from cannabis by manufacturing as defined herein, and does not mean a
product that contains or is derived from hemp.
Cannabis waste means cannabis or cannabis-derived product discarded by a
manufacturing, packaging, labeling, or holding operation.
Compliant individual means an individual who has met all legal requirements to obtain
and use cannabis or cannabis-derived product in the jurisdiction where this part applies.
Composition means the aggregate mixture which results from the manufacture of a
cannabis-derived product according to the formula and process defined in the product’s
manufacturing protocol.

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Component means any substance or item intended for use in the manufacture of a
cannabis-derived product, including those that do not appear in the batch of the
cannabis-derived product. Component includes cannabis, cannabis-derived products
used as ingredients, other ingredients, and processing aids.
Contact surface means any surface that directly contacts cannabis, components, or
cannabis-derived product, and any surface from which drainage onto cannabis,
components, or cannabis-derived product, or onto surfaces that contact cannabis,
components, or cannabis-derived product, may occur during the normal course of
operations.
Controlled access area means an area in the physical plant designed to prevent entry
by anyone except authorized personnel.
Cultivate means to grow, harvest, dry, and cure cannabis. A person, group of persons,
non-profit entity, or business entity that cultivates is a cultivator, and a facility where
cannabis plants are cultivated is a cultivation operation.
Dispense means to provide cannabis or cannabis-derived product to compliant
individuals.
Dispensing operation means a person, group of persons, non-profit entity, or business
entity that provides cannabis or cannabis-derived product to compliant individuals and
includes delivery services, direct-from-garden operations, growing co-ops, and
storefront operations.
Disposition means review and approval or rejection of a batch, lot, or other item by
quality control personnel.
Gang-printed label means a label for one product that is printed simultaneously on the
same sheet of paper as labels for other products.
Hemp means any part of a plant in the genus Cannabis, whether growing or not, with a
delta-9 tetrahydrocannabinol concentration of not more than 0.3 (three-tenths) percent
on a dry weight basis.
Hold means to store or warehouse cannabis or cannabis-derived product in any context
by an operation that is subject to this rule. A person, group of persons, non-profit entity,
or business entity that holds is a holder, and a facility where holding occurs is a holding
operation.
Identity means the set of characteristics by which an ingredient or product is definitively
recognizable or known. In the case of cannabis and other botanical ingredients, identity
means the plant part and the botanical genus, species, variety, strain, and/or cultivar, as
well as any other applicable characteristics as stated on the label or other labeling. In
the case of cannabis-derived products, identity means the product name, strength, key
features of its form or composition, grade, and/or other characteristics as applicable.

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Ingredient means any substance that is used in the manufacture of a cannabis-derived
product and that is intended to be present in the batch of the cannabis-derived product.
In-process material means any material that is compounded, blended, ground,
extracted, sifted, sterilized, or prepared in any other way by the operation for use in its
manufacturing, packaging, or labeling of cannabis or a cannabis-derived product.
Label (verb) means to affix labeling on packaged cannabis or cannabis-derived product.
A person, group of persons, non-profit entity, or business entity that labels is a labeler,
and a facility where labeling occurs is a labeling operation.
Labeling (noun) means all labels and other written, printed or graphic matter on or
accompanying any article or any of its containers or wrappers.
Lot means a batch, or a specific identified portion of a batch, that is uniform and that is
intended to meet specifications for identity, purity, strength, and composition; or, in the
case of a cannabis-derived product produced by continuous process, a specific
identified amount produced in a specified unit of time or quantity in a manner that is
uniform and that is intended to meet specifications for identity, purity, strength, and
composition.
Manufacture means to compound, blend, grind, extract, or otherwise make or prepare
cannabis-derived product; the term does not apply to cannabis. A person, group of
persons, non-profit entity, or business entity that manufactures is a manufacturer, and a
facility where manufacture occurs is a manufacturing operation.
May is used to indicate an action or activity that is permitted; may not is used to indicate
an action or activity that is not permitted.
Microorganism means yeasts, molds, bacteria, viruses, and other similar microscopic
organisms having public health or sanitary concern. This definition includes species that
may cause a component or cannabis or cannabis-derived product to decompose; may
indicate that the component or cannabis or cannabis-derived product is contaminated
with filth; or otherwise may cause the component, cannabis or cannabis-derived product
to be adulterated.
Must is used to state a requirement.
Package (verb) means to place cannabis or cannabis-derived product into primary
packaging for bulk or retail distribution when performed by an operation subject to this
part. A person, group of persons, non-profit entity, or business entity that packages is a
packager, and a facility where packaging occurs is a packaging operation.
Pack (verb) means to place cannabis or cannabis-derived product into containers for
distribution, other than to package the cannabis or cannabis-derived product; and
includes the placement of cannabis into any type of containers by cultivation operations,
processing operations, and dispensing operations, as well as the placement of filled
primary packaging containers into other containers such as for storage or transport.

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Packaging component means any item intended for use in the primary packaging or
labeling of cannabis-derived products.
Personnel means any worker engaged in the performance of operations subject to this
rule and includes full and part-time employees, temporary employees, contractors, and
volunteers.
Pest means any objectionable insect or other animal at any life stage.
Physical plant means all or any part of a building or facility used for or in functional
connection with manufacturing, packaging, labeling, or holding a cannabis-derived
product.
Primary packaging means items used in packaging that serve to directly contain,
contact, and/or label the product.
Process (verb) means to trim, inspect, grade, or pack cannabis. A person, group of
persons, non-profit entity, or business entity that processes is a processor, and a facility
where cannabis is processed is a processing operation.
Product complaint means any communication that contains any allegation, written,
electronic, or oral, expressing concern, for any reason, with the quality of a product that
could be related to its manufacture, packaging, or labeling.
Production means manufacturing, packaging, and/or labeling, as applicable to the firm’s
operations.
Purity means the relative freedom from extraneous matter, contaminants, or impurities,
whether or not harmful to the consumer or deleterious to the product.
Quality means that the product consistently meets the established specifications for
identity, purity, strength, composition, packaging, and labeling, and has been
manufactured, packaged, labeled, and held under conditions to prevent adulteration.
Quality control means a planned and systematic operation or procedure for ensuring the
quality of a product.
Quality control personnel means any person, persons, or group, within or outside of a
manufacturing, packaging, labeling or holding operation, which is designated to be
responsible for the operation’s quality control operations.
Quarantine means to segregate and withhold from use lots, batches, or other portions of
components, packaging components, in-process materials, cannabis, or products
whose suitability for use must be determined by quality control personnel.
Representative sample means a sample that consists of an adequate quantity of
material or number of units that is collected in a manner intended to ensure that the
sample accurately portrays the material being sampled.

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Reprocessing means the performance of a treatment, adjustment, repackaging,
relabeling, or other deviation from standard procedures or from the applicable
manufacturing protocol, in order to render a nonconforming material suitable for use.
Reserve sample means a representative sample of component, packaging component,
or product that is held for a designated period of time.
Sanitize means to adequately treat cleaned equipment, containers, utensils, or any
other cleaned contact surface by a process that is effective in destroying vegetative
cells of microorganisms of public health significance, and in substantially reducing
numbers of other microorganisms, but without adversely affecting the product or its
safety for the consumer.
Should is used to state recommended or advisory procedures.
Strength means the potency of cannabis or a cannabis-derived product, whether
expressed as (a) the amount or percent of specific chemical constituents or groups of
chemical constituents; (b) the concentration or amount of cannabis present in a
cannabis-derived product; or (c), in the case of cannabis extracts, the ratio of the input
quantity of crude cannabis, on a dry weight basis, to the output quantity of finished
extract.
Theoretical yield means the quantity that would be produced at any appropriate step of
manufacture or packaging of a particular cannabis-derived product, based upon the
quantity of components or packaging to be used, in the absence of any loss or error in
actual production.
Water activity (aw) is a measure of the free moisture in a component or product and is
the quotient of the water vapor pressure of the substance divided by the vapor pressure
of pure water at the same temperature.
Vendor means a person, group of persons, non-profit entity, or business entity that
supplies cannabis or cannabis-derived product to manufacturing, packaging, labeling or
holding operations, and may be either the direct representative of a cultivation,
processing, or manufacturing operation, or may function independently of such
operations by purchasing cannabis or cannabis-derived product from such operations
and reselling it to other operations.
SUBPART B – GENERAL REQUIREMENTS

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Section 2.1 Acquisition of cannabis and cannabis-derived products
Manufacturing, packaging, labeling, and holding operations may obtain cannabis or
cannabis-derived product from any of the following as allowed by applicable legislation
and regulation:
(1) Cultivation operations;
(2) Processing operations;
(3) Vendors;
(4) Other manufacturing, packaging, labeling or holding operations; and
(5) Any other legal entity as allowed in this jurisdiction.
Section 2.2 Distribution of cannabis and cannabis-derived products

(a) Manufacturing, packaging, labeling and holding operations may distribute cannabis
and cannabis-derived products to any of the following as allowed by applicable
legislation and regulation:
(1) Dispensing operations;
(2) Other manufacturing, packaging, labeling or holding operations subject to this
section;
(3) Vendors; and
(4) Any other legal entity as allowed in this jurisdiction.
(b) Manufacturing, packaging, labeling and holding operations that transport cannabis or
cannabis-derived products must do so in a secured enclosed container and/or
secured cargo area of the delivery vehicle.
Section 2.3 Ancillary operations

In addition to the manufacturing of cannabis-derived product and the packaging,
labeling or holding of cannabis or cannabis-derived product, an operation described in
section 1.1 may also engage in other operations, so long as such operations are
permitted at this location in the jurisdiction in which this part applies.
SUBPART C – PERSONNEL

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Section 3.1 Personnel training
(a) Manufacturing, packaging, labeling and holding operations must:
(1) Ensure that each person engaged in the operation has the education,
training, and experience, or any combination thereof, to enable that person to
perform all assigned functions;
(2) Provide personnel with training in the applicable requirements of this part; and
(3) Maintain records of any training provided to personnel for the performance of
all assigned functions.
(b) Personnel training should include:
(1) Instructions regarding regulatory inspection preparedness and law-
enforcement interactions; and
(2) Information on U.S. federal, state and local laws, regulations, and policies
relating to individuals employed in these operations, and the implications of
these for such personnel.
Section 3.2 Personnel responsibilities

(a) Measures must be taken to exclude from any operation any person that might be a
source of microbial contamination due to a health condition through contact with any
material, including components, packaging components, in-process materials,
cannabis, cannabis-derived products, and contact surfaces used in manufacturing,
packaging, labeling, and holding operations. Such measures include the following:
(1) Excluding from working in any operations that may result in contamination
any person who, by medical examination, the person's acknowledgement, or
supervisory observation, is shown to have, or appears to have, an illness,
infection, open lesion, or any other abnormal source of microbial
contamination, that could result in microbial contamination of components,
packaging components, in-process materials, cannabis, cannabis-derived
products, or contact surfaces, until the health condition no longer exists; and
(2) Instructing personnel to notify their supervisor(s) if they have or if there is a
reasonable possibility that they have a health condition described in
paragraph (a)(1) of this section that could result in microbial contamination of
any components, packaging components, in-process materials, cannabis,
cannabis-derived products, or any contact surface.
(b) Personnel working in an operation during which adulteration of components,
packaging components, cannabis, cannabis-derived products, or contact surfaces
could occur must use hygienic practices to the extent necessary to protect against
such contamination of components, packaging components, in-process materials,

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cannabis, cannabis-derived products, or contact surfaces. These hygienic practices
include the following:
(1) Wearing outer garments in a manner that protects against the contamination
of components, packaging components, in-process materials, cannabis,
cannabis-derived products, or any contact surface;
(2) Maintaining adequate personal cleanliness;
(3) Washing hands thoroughly with soap (and sanitizing if necessary to protect
against contamination with microorganisms):
(i) Before starting work;
(ii) After using the restroom; and
(iii) At any other time when the hands may have become soiled or
contaminated;
(4) Removing all unsecured jewelry and other objects that might fall into
components, packaging components, cannabis, cannabis-derived products,
equipment, or packaging, and removing hand jewelry that cannot be
adequately cleaned during periods in which components, packaging
components, in-process materials, cannabis, or cannabis-derived products
are manipulated by hand. If hand jewelry cannot be removed, it must be
covered by material that is maintained in an intact, clean, and sanitary
condition and that effectively protects against contamination of components,
products, or contact surfaces;
(5) Maintaining gloves used in handling components, packaging components, in-
process materials, cannabis, or cannabis-derived products in an intact, clean,
and sanitary condition. The gloves should be of an impermeable material;
(6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard
covers, or other effective hair restraints;
(7) Not storing clothing or other personal belongings in areas where components,
products, or any contact surfaces are exposed or where contact surfaces are
washed;
(8) Not eating food, chewing gum, drinking beverages, or using tobacco products
in areas where components, packaging components, in-process materials,
cannabis, cannabis-derived products, or any contact surfaces are exposed, or
where contact surfaces are washed;
(9) Taking any other precautions necessary to protect against the contamination
of components, packaging components, in-process materials, cannabis,
cannabis-derived products, or contact surfaces with microorganisms, filth, or

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any other extraneous materials, including perspiration, hair, cosmetics,
tobacco, chemicals, and medicines applied to the skin;
(10) Taking all precautions necessary to maintain the security of the physical
plant, to prevent unauthorized access to controlled access areas, and to
maintain strict control of in-process materials, cannabis, cannabis-derived
products, and cannabis waste; and
(11) Entering controlled access areas only as authorized by supervisory
personnel.
Section 3.3 Personnel safety

(a) Policies must be implemented to protect personnel in all operations and provide
personnel with adequate safety training to comply with these policies. Such policies
should be similar to personnel safety policies in comparable industries, such as food
processors, and may include, for example:
(1) Personnel accident reporting and investigation policies;
(2) Fire prevention and response plans;
(3) Materials handling and hazard communications policies, including
maintenance of material safety data sheets (MSDS); and
(4) Personal protective equipment policies.
(b) An emergency contact list must be visibly posted and maintained which includes at a
minimum:
(1) Operation manager contacts;
(2) Emergency responder contacts;
(3) Poison control contacts;
(4) Fire department contacts; and
(5) Spill response team contacts.
(c) Compliance must also be ensured with all other applicable standards of the federal
Occupational Health and Safety Administration and any applicable state or local
worker safety requirements.
Section 3.4 Supervisor requirements

(a) Qualified personnel should be assigned to supervise the manufacturing, packaging,
labeling, or holding of cannabis and cannabis-derived products.

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(b) Each person responsible for supervising the manufacture, packaging, labeling, or
holding of a cannabis or cannabis-derived product must have the education, training,
and experience, or any combination thereof, to perform assigned functions in such a
manner as to provide assurance that the cannabis or cannabis-derived product has
the identity, purity, strength, and composition that it purports or is represented to
possess.
(c) One or more qualified personnel should be assigned to supervise overall sanitation.
Each of these supervisors must be qualified by education, training, or experience to
develop and supervise sanitation procedures.
SUBPART D – PHYSICAL PLANT AND GROUNDS
Section 4.1 Design and construction

(a) The physical plant used in the manufacture, packaging, labeling, or holding of
cannabis and cannabis-derived products must be suitable in size, construction, and
design to facilitate maintenance, cleaning and/or sanitizing, as applicable to the
operation.
(b) Any such physical plant must have adequate space for the orderly placement of
equipment and materials to prevent mixups of components, packaging components,
in-process materials, cannabis, or cannabis-derived products during manufacturing,
packaging, labeling, or holding.
(c) Any such physical plant must be designed to reduce the potential for contamination
of components, packaging components, cannabis, cannabis-derived products, or
contact surfaces, with microorganisms, chemicals, filth, or other extraneous material.
The design and construction must include:
(1) Floors, walls, and ceilings that can be adequately cleaned and kept clean and
in good repair;
(2) Fixtures, ducts, and pipes that do not contaminate components, packaging
components, in-process materials, cannabis or cannabis-derived products, or
contact surfaces by dripping or other leakage, or condensate;
(3) Aisles or working spaces between equipment and walls that are adequately
unobstructed and of adequate width to permit all persons to perform their
duties and to protect against contamination of components, packaging
components, in-process materials, cannabis or cannabis-derived products, or
contact surfaces with clothing or personal contact.

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(4) Safety-type light bulbs, fixtures, skylights, or other glass or glass-like
materials must be used when the light bulbs, fixtures, skylights or other glass
or glass-like materials are suspended over exposed components, packaging
components, in-process materials, or cannabis or cannabis-derived products,
unless the physical plant is otherwise constructed in a manner that will protect
against contamination of components, packaging components, in-process
materials, or cannabis or cannabis-derived products in case of breakage of
glass or glass-like materials.
(d) Any such physical plant must have separate or defined areas, or other control
systems such as computerized inventory controls or automated systems of
separation, to prevent cross-contamination and mixups of components, cannabis, or
cannabis-derived products during any of following operations that take place in the
physical plant:
(1) Receipt, identification, storage, and withholding from use of quarantined
components, packaging components, in-process materials, cannabis, or
cannabis-derived products pending disposition by quality control personnel;
(2) Storage of approved components, packaging components, cannabis, or
cannabis-derived products;
(3) Storage of rejected components, packaging components, in-process
materials, cannabis, cannabis-derived products, and cannabis waste pending
return to their supplier or destruction;
(4) Storage of in-process materials pending normal further processing;
(5) Storage of components, packaging components, in-process materials, and
products pending reprocessing;
(6) Manufacturing operations;
(7) Packaging and labeling operations;
(8) Separation of the manufacturing, packaging, labeling, and holding of different
product types including different types of cannabis or cannabis-derived
products and other products handled in the same physical plant;
(9) Performance of laboratory analyses and storage of laboratory supplies and
samples, as applicable;
(10) Cleaning and sanitation of contact surfaces.
(e) Water must be provided that is:
(1) Safe and sanitary, at suitable temperatures, and under pressure as needed,
for all uses where water does not become a component of the cannabis-
derived product; and

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(2) Compliant with applicable state and local potable water requirements and with
other requirements as necessary to ensure the water does not contaminate
the cannabis-derived product, for all uses where such water may become a
component of the cannabis-derived product, e.g., when such water contacts
components, packaging components, in-process materials, cannabis or
cannabis-derived products, or any contact surface.
(f) Heating, ventilating, cooling, and air filtration must be installed and maintained in the
physical plant as needed to ensure the quality of the product.
(1) Ventilation equipment such as filters, fans, exhausts, dust collection, and
other air-blowing equipment must be provided in areas where odors, dust,
and vapors (including steam and noxious fumes) may contaminate
cannabis-derived products, or contact surfaces.
(2) When fans, compressed air, or other air-blowing equipment are used, such
equipment must be designed, located, and operated in a manner that
minimizes the potential for microorganisms and particulate matter to
contaminate components, packaging components, in-process materials,
cannabis, cannabis-derived products, or contact surfaces.
(3) Equipment that controls temperature, humidity, and/or microorganisms must
be provided, when such equipment is necessary to ensure the quality of the
product.
(g) The plumbing in the physical plant must be of an adequate size and design and be
adequately installed and maintained to:
(1) Carry sufficient amounts of water to required locations throughout the
physical plant;
(2) Properly convey sewage and liquid disposable waste from the physical plant;
(3) Avoid being a source of contamination to components, packaging
components, in-process materials, cannabis or cannabis-derived products,
water supplies, or any contact surface, or creating an unsanitary condition;
(4) Provide adequate floor drainage in all areas where floors are subject to
flooding-type cleaning or where normal operations release or discharge water
or other liquid waste on the floor; and
(5) Not allow backflow from, or cross connection between, piping systems that
discharge waste water or sewage and piping systems that carry water used
for manufacturing cannabis-derived products, for cleaning contact surfaces,
or for use in bathrooms or hand-washing facilities.
(h) Personnel must be provided with adequate, readily accessible toilet facilities that
are:

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(1) Maintained in a clean and sanitary condition;
(2) Adequately stocked with toilet paper, soap, and single use paper towels or
other drying devices;
(3) Kept in good repair at all times;
(4) Equipped with signage advising personnel of the necessity of washing hands
prior to returning to work;
(5) Prohibited from being used for activities that support production operations,
such as cleaning of production equipment or utensils.
(i) Airborne contamination from toilet facilities must be prevented from contacting
components, packaging components, in-process materials, cannabis, cannabis-
derived products, or contact surfaces, for example by providing adequate physical
separation of toilet facilities from manufacturing, packaging, labeling, and holding
operations, or by use of negative air pressure within the toilet facility.
(j) Adequate and convenient hand-washing facilities must be provided that are:
(1) Provided with running water of suitable temperature;
(2) Provided with effective hand cleaning and/or sanitizing preparations and
single use paper towels or other drying devices;
(3) Located at points in the facility where good sanitary practices require
personnel to wash their hands;
(4) Prohibited from being used for activities that support production operations,
such as cleaning of production equipment or utensils.
(k) Adequate lighting must be provided in:
(1) All areas where components, packaging components, in-process materials,
cannabis, or cannabis-derived products are examined, manufactured,
packaged, labeled, or held;
(2) All areas where contact surfaces are cleaned; and
(3) Hand-washing areas, dressing and locker rooms, and toilet facilities.
Section 4.2 Sanitation requirements

(a) The grounds of the physical plant must be kept in a condition that protects against
the contamination of components, packaging components, in-process materials,
cannabis, cannabis-derived products, or contact surfaces. The methods for
adequate ground maintenance include:

- 16 -
(1) Properly storing equipment, removing litter and waste, and cutting weeds or
grass within the immediate vicinity of the physical plant so that it does not
attract pests, harbor pests, or provide pests a place for breeding;
(2) Maintaining roads, yards, and parking lots so that they do not constitute a
source of contamination in areas where components, packaging components,
in-process materials, cannabis, cannabis-derived products, or contact
surfaces are exposed;
(3) Adequately draining areas that may contribute to the contamination of
cannabis-derived products, or contact surfaces by seepage, filth or any other
extraneous materials, or by providing a breeding place for pests;
(4) Adequately operating systems for waste treatment and disposal so that they
do not constitute a source of contamination in areas where components,
packaging components, in-process materials, cannabis or cannabis-derived
products, or contact surfaces are exposed; and
(5) If the plant grounds are bordered by grounds not under the operation’s
control, and if those other grounds are not maintained in the manner
described in this section, care should be exercised in the plant by inspection,
extermination, or other means to exclude pests, dirt, and filth or any other
extraneous materials that may be a source of contamination.
(b) The physical plant must be maintained in a clean and sanitary condition and must be
maintained in repair sufficient to prevent components, packaging components, in-
process materials, cannabis, cannabis-derived products, or contact surfaces from
becoming contaminated.
(c) Cleaning compounds, sanitizing agents, pesticides, and other toxic materials must
be appropriately stored, handled, and controlled.
(1) Cleaning compounds and sanitizing agents must be free from
microorganisms of public health significance and be safe and adequate under
the conditions of use.
(2) Toxic materials must not be used or held in a physical plant in which
components, packaging components, in-process materials, cannabis,
cannabis-derived products, or contact surfaces are manufactured or exposed,
unless those materials are necessary as follows:
(i) To maintain clean and sanitary conditions;
(ii) For use in laboratory testing procedures, where applicable;
(iii) For maintaining or operating the physical plant or equipment; or
(iv) For use in the plant's operations.

- 17 -
(3) Cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, and
other toxic materials must be identified, stored, and used in a manner that
protects against contamination of components, packaging components, in-
process materials, cannabis, cannabis-derived products, or contact surfaces.
(d) Adequate pest control must be provided.
(1) Animals or pests must not be allowed in any area of the physical plant, except
that guard or guide dogs may be allowed in some areas of the physical plant
if the presence of the dogs will not result in contamination of components,
packaging components, in-process materials, cannabis or cannabis-derived
products, or contact surfaces;
(2) Effective measures must be taken to exclude pests from the physical plant
and to protect against contamination of components, packaging components,
in-process materials, cannabis or cannabis-derived products, and contact
surfaces on the premises by pests; and
(3) Insecticides, fungicides, or rodenticides must not be used in or around the
physical plant, unless they are registered with EPA and used in accordance
with the label instructions, and effective precautions are taken to protect
against the contamination of components, packaging components, in-process
materials, cannabis or cannabis-derived products, or contact surfaces.
(e) Trash must be regularly conveyed, stored, and disposed in order to:
(1) Minimize the development of odors;
(2) Minimize the potential for the trash to attract, harbor, or become a breeding
place for pests;
(3) Protect against contamination of components, packaging components, in-
process materials, cannabis, cannabis-derived products, any contact surface,
water supplies, and grounds surrounding the physical plant; and
(4) Control hazardous waste to prevent contamination of components, packaging
components, in-process materials, cannabis or cannabis-derived products,
and contact surfaces.
(f) Manufacturing, packaging, labeling, or holding operations must have and follow
written procedures for sanitation that address the following:
(1) Responsibility for sanitation;
(2) Detailed description of the cleaning schedules, methods, equipment, and
materials to be used in cleaning the grounds and buildings; and
(3) Records of cleaning and sanitation that must be kept.

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(g) Manufacturing, packaging, labeling, and holding operations must have and follow
written procedures for use of rodenticides, insecticides, fungicides, fumigating
agents, and cleaning and sanitizing agents that address the following:
(1) Prevention of the contamination of components, packaging components, in
process materials, cannabis, cannabis-derived products, or contact surfaces;
and
(2) Records of the use of rodenticides, insecticides, fungicides, fumigating
agents, and cleaning or sanitizing agents must be kept.
(h) Sanitation procedures must apply to work performed by all personnel during the
ordinary course of operations.
(i) All operations must be conducted in accordance with adequate sanitation principles,
including, but not limited to:
(1) Cleaning and/or sanitizing production equipment, containers, and other
contact surfaces, as needed;
(2) Controlling airborne contamination as needed where components, packaging
components, in-process materials, product, or contact surfaces are exposed;
(3) Using sanitary handling procedures.
Section 4.3 Equipment and utensils

(a) Production operations must use equipment and utensils that are of appropriate
design, construction, and workmanship.
(1) Equipment and utensils must be suitable for their intended use;
(2) Equipment and utensils must be able to be adequately cleaned and properly
maintained; and
(3) Use of equipment and utensils must not result in the contamination of
components, packaging components, in-process materials, cannabis,
cannabis-derived products, or contact surfaces.
(b) All equipment and utensils used in production operations must be:
(1) Installed and maintained to facilitate cleaning of the equipment, utensils, and
adjacent spaces;
(2) Constructed so that contact surfaces are nontoxic and corrosion-resistant,
and neither reactive nor absorptive;
(3) Designed and constructed to withstand the environment in which they are
used, the action of components, in-process materials, cannabis, or cannabis-

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derived products and, if applicable, cleaning compounds and sanitizing
agents; and
(4) Maintained to protect components, in-process materials, cannabis, and
cannabis-derived products from being contaminated by any source.
(c) Equipment and utensils must be designed and maintained to minimize accumulation
of dirt, filth, organic material, particles of components, in-process materials,
cannabis, and cannabis-derived products, or any other extraneous materials or
contaminants.
(d) Compressed air or other gases introduced mechanically into or onto a component,
packaging component, in-process material, cannabis or cannabis-derived product, or
contact surface or used to clean any contact surface must be filtered or otherwise
treated such that the component, packaging component, in-process material,
cannabis or cannabis-derived product, or contact surface is not contaminated.
(e) Each freezer, refrigerator, and other cold storage compartment used to hold
components, in-process materials, or cannabis or cannabis-derived products:
(1) Must be fitted with an indicating thermometer, temperature-measuring device,
or temperature-recording device that indicates and records, or allows for
recording by hand, the temperature accurately within the compartment; and
(2) Must have an automated device for regulating temperature and/or an
automated alarm system to indicate a significant temperature change.
(f) Instruments or controls used in manufacturing, packaging, labeling, holding, or
testing, and instruments or controls that are used to measure, regulate, or record
conditions that control or prevent the growth of microorganisms or other
contamination, must be suitably accurate and precise, and adequately maintained.
(g) Where appropriate, instruments and controls used in manufacturing, packaging,
holding, or testing components, packaging components, in-process materials,
cannabis, and cannabis-derived products must be calibrated, inspected, or
otherwise verified before first use and at routine intervals or as otherwise necessary
to ensure the accuracy and precision of the instrument or control, and the resulting
data must be periodically reviewed by quality control personnel. Instruments or
controls that are past their calibration, inspection, or verification due date, or which
cannot be adjusted to provide suitable accuracy and precision, must be removed
from use until they are repaired or replaced.
(h) Production operations must establish and use appropriate controls for automated,
mechanical, and electronic equipment (including software for a computer controlled
process) to ensure that:
(1) Any changes to the equipment are approved by quality control personnel and
instituted only by authorized personnel; and

- 20 -
(2) The equipment functions in accordance with its intended use.
(i) Equipment and utensils, and any other contact surfaces used in production
operations must be maintained, cleaned, and sanitized, as necessary.
(1) Equipment and utensils must be taken apart as necessary for thorough
maintenance, cleaning, and sanitizing.
(2) All contact surfaces used for manufacturing, packaging, or holding low-
moisture components, in-process materials, or cannabis or cannabis-derived
products, must be in a dry and sanitary condition when in use. When the
surfaces are wet-cleaned, they must be sanitized, when necessary, and
thoroughly dried before subsequent use.
(3) If wet processing is used during production, all contact surfaces must be
cleaned and sanitized, as necessary, to protect against the introduction of
microorganisms into components, packaging components, in-process
materials, or cannabis or cannabis-derived products.
(4) When cleaning and sanitizing is necessary, all contact surfaces must be
cleaned before use and after any interruption during which the contact
surface may have become contaminated.
(5) If contact surfaces are used in a continuous production operation or in
consecutive operations involving different batches of the same product, the
contact surfaces must be adequately cleaned and sanitized, as necessary.
(6) Surfaces that do not come into direct contact with components, packaging
components, in-process materials, or cannabis or cannabis-derived products
must be cleaned as frequently as necessary to protect against contaminating
components or products.
(7) Single-service articles (such as utensils intended for one-time use, paper
cups, and paper towels) must be stored in appropriate containers, and
handled, dispensed, used, and disposed of in a manner that protects against
contamination of components, packaging components, in-process materials,
cannabis or cannabis-derived products, or any contact surface.
(8) Cleaning compounds and sanitizing agents must be adequate for their
intended use and safe under their conditions of use.
(9) Cleaned and sanitized portable equipment and utensils that have contact
surfaces must be stored in a location and manner that protects them from
contamination.
(j) There must be written procedures for calibration, maintenance, cleaning, and
sanitation of equipment, instruments, and utensils, and records of these activities
must be kept.

- 21 -
Section 4.4 Security requirements
(a) Security procedures must be established and implemented for authorized access to
the physical plant and any controlled access areas therein.
(b) Access to the physical plant and controlled access areas must be limited to current
personnel and contractors as appropriate to their job function.
(c) The physical plant must be equipped with one or more controlled access areas for
storage of the following:
(1) Labels and other packaging components;
(2) Cannabis and cannabis-derived products;
(3) Cannabis waste;
(4) Quarantined components, packaging components, in-process materials, and
cannabis or cannabis-derived products;
(5) Rejected components, packaging components, in-process materials,
cannabis, or cannabis-derived products.
(d) There must be written procedures for security.
SUBPART E – MANUFACTURING PROCESS CONTROLS
Section 5.1 Manufacturing protocol

(a) Manufacturing operations must prepare and follow a manufacturing protocol for each
unique formulation of cannabis-derived product to be produced. The manufacturing
protocol must include the following, as applicable:
(1) Identity of the product;
(2) For each formulation of product:
(i) Nominal batch size;
(ii) Identity of each component to be used in the batch;
(iii) Weight or measure of each component to be used in the batch,
including the unit of measure and a statement of any range or variation
in the weight or measure;
(iv) A statement of any intentional overage amount of a component; and

- 22 -
(v) Name and amount of each ingredient that will be declared on the
product’s labeling.
(3) A statement of theoretical yield for each significant process step and at the
end of manufacture, including the acceptable maximum and minimum
percentages of theoretical yield;
(4) Written instructions or cross references to standard procedures for the
following:
(i) The execution of each process step;
(ii) Production process specifications per section 5.5;
(iii) Monitoring of production process specifications;
(iv) In-process material specifications per section 5.8;
(v) In-process material sampling, testing, and/or examination;
(vi) Cannabis-derived product sampling, testing, and/or examination; and
(vii) Additional applicable procedures to be followed, if any.
(5) Cannabis-derived product specifications, or a cross-reference to cannabis-
derived product specification documents.
(b) Manufacturing protocols must be written with the intent to provide not less than 100
percent of the labeled or specified amount of cannabis and any other ingredient for
which a quantitative label claim is made, throughout the shelf life of the product.
(c) The production process described in the manufacturing protocol must ensure that
cannabis-derived product specifications are consistently met.
Section 5.2 Manufacturing component control requirements

(a) Manufacturing operations must have written procedures describing in sufficient detail
the receipt, identification, storage, handling, sampling, review, and approval or
rejection of components.
(b) Each container or grouping of containers for components must be identified with a
distinctive code (i.e. lot or control number) for each lot in each shipment received,
which allows the lot to be traced backward to the supplier, the date received, and the
name of the component; and forward to the cannabis-derived product batches
manufactured or distributed using the lot. This code must be used in recording the
disposition of each lot.
(c) Specifications for each component must be established as follows, to the extent they
are necessary to ensure that manufactured batches of cannabis-derived product
meet specifications.

- 23 -
(1) An identity specification for the component must be established;
(2) Specifications for the strength and composition of the component must be
established as necessary to ensure the strength and composition of
cannabis-derived products manufactured with the component;
(3) Specifications for the purity of the component must be established as
necessary to ensure the purity of cannabis-derived products manufactured
with the component, including limits on those types of contamination that may
adulterate or may lead to adulteration of cannabis-derived products
manufactured with the component, such as filth, insect infestation,
microbiological contamination, or other contaminants.
(d) Components must be received and stored pending approval as follows:
(1) Upon receipt and before acceptance, each container or grouping of
containers must be examined visually for appropriate labeling as to contents,
container damage or broken seals, and contamination, to determine whether
the container condition may have resulted in contamination or deterioration of
the components.
(2) The supplier’s documentation for each shipment must be examined to ensure
the components are consistent with what was ordered.
(3) Components must be stored under quarantine until they have been sampled,
reviewed, and approved or rejected by quality control personnel.
(e) Components must be approved or rejected as follows:
(1) Each lot of components must be withheld from use until the lot has been
sampled, reviewed, and released for use by the quality control personnel.
(2) Compliance of the lot with established specifications must be ensured either
through review of the supplier's certificate of analysis or other documentation,
or through appropriate tests and/or examinations. Any tests and examinations
performed must be conducted using appropriate scientifically valid methods.
(3) Any lot of a component that meets its specifications may be approved and
released for use for use by quality control personnel.
(4) Any lot of a component that does not meet its specifications must be rejected by
quality control personnel, unless quality control personnel approve a treatment,
process adjustment, reprocessing, or other deviation that will render the component
or packaging component suitable for use, and will ensure the finished cannabis
product batches manufactured with the affected lot will meet all specifications for
identity, purity, strength, and composition and will not be otherwise contaminated or
adulterated. Any such treatment, process adjustment, reprocessing, or other
deviation must be documented, justified, and approved by quality control personnel.

- 24 -
Section 5.3 Manufacturing batch record
(a) The manufacturing operation must prepare a manufacturing batch record for each
batch of cannabis-derived product manufactured.
(b) The manufacturing batch record must:
(1) Cross-reference or reproduce the appropriate manufacturing protocol; and
(2) Form a complete record of the manufacturing and control of the batch.
(c) Each batch must be assigned a batch, lot, or control number which allows the
complete history of the production and distribution of the batch to be determined.
This code must be used in recording the disposition of each batch.
(d) The manufacturing batch record must include, as applicable to the process:
(1) Identity of the cannabis-derived product;
(2) The batch, lot, or control number of the cannabis-derived product;
(3) Batch size;
(4) For each component used in production of the batch:
(i) Identity of each component used in the batch;
(ii) Batch, lot, or control number of each component used in the batch;
(iii) Actual weight or measure of each batch or lot of component used in
the batch, including the unit of measure;
(5) Date(s) on which, and where applicable the time(s) at which, each step of the
manufacturing process was performed;
(6) Actual results obtained during monitoring of production process parameters;
(7) Identity of processing lines and major equipment used in producing the batch;
(8) Date and where applicable the time of the maintenance, cleaning, and/or
sanitizing of the major equipment used in producing the batch, or a cross-
reference to records, such as individual equipment logs, where this
information is recorded;
(9) If manufacture of the batch uses equipment or instruments requiring periodic
calibration, inspection, or verification, the date and where applicable the time
of the last calibration, inspection, or verification or the date on which such is
next due; or a cross-reference to records, such as individual equipment logs,
where this information is recorded;
(10) A statement of the actual yield and a statement regarding whether the actual
yield is within the acceptable range of the theoretical yield as per section
5.1(a)(3) after each significant process step and at the end of manufacturing;

- 25 -
(11) Records of any cannabis waste generated during production of the batch;
(12) Records of any treatment, process adjustment, reprocessing, or other
deviation that occurred during production of the batch;
(13) Records of the date, time where applicable, quantity, and person
responsible for any sample removed during or after production;
(14) Actual results of any testing or examination of in-process material or
cannabis-derived product, or a cross-reference to such results;
(15) Documentation that the cannabis-derived product meets its specifications for
identity, purity, strength, and composition, in accordance with the
requirements of the manufacturing protocol;
(16) Identity of each person performing each process step in production of the
batch, including but not limited to:
(i) Weighing or measuring each component and verifying the weight or
measure of each component used in the batch per section 5.4;
(ii) Adding each component to the batch and verifying the addition of each
component to the batch per section 5.4;
(iii) Monitoring production process parameters;
(iv) Performing and verifying calculations of the actual yield and any other
mathematical calculations;
(v) Directly overseeing each stage of production of the batch;
(vi) Performing any other checks or verifications in production of the batch,
as needed; and
(vii) Releasing the batch from one stage of production to the next.
(e) All data in the manufacturing batch record must be recorded at the time at which
each action is performed.
(f) The completed manufacturing batch record for each batch must be reviewed and
signed by quality control personnel to determine compliance with all applicable
specifications and other requirements of the manufacturing protocol before a batch
is approved.
Section 5.4 Allocation and charge-in of components

(a) Manufacturing operations must weigh, measure, or subdivide components to be
used in a cannabis-derived product batch as appropriate for the batch.
(b) If a component is removed from the original container to another, the new container
must be identified with the following information:

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(1) Component identity;
(2) Batch, lot, or control number;
(3) Weight or measure in the new container; and
(4) Batch for which component was dispensed, including its identity and batch,
lot, or control number.
(c) Each container of component dispensed to manufacturing must be examined by a
second person or verified by automated equipment to assure that:
(1) The component was released by quality control personnel;
(2) The weight or measure is correct as stated in the manufacturing protocol; and
(3) The containers are properly identified.
(d) Each component must either be added to the batch by one person and verified by a
second person or, if the components are added by automated equipment, verified by
one person.
Section 5.5 Process monitoring and controls during manufacturing

(a) Process specifications must be established for production process parameters at or
during any point, step, or stage where control is necessary to ensure the quality of
the batch of cannabis-derived product, and to detect any unanticipated occurrence
that may result in contamination, adulteration, or a failure to meet specifications. The
process parameters to be monitored may include, but are not limited to, the following
as appropriate:
(1) Time;
(2) Temperature;
(3) Pressure; and
(4) Speed.
(b) Production process parameters must be monitored at or during any point, step, or
stage where process specifications have been established.
(c) Any deviation from the specified process parameters must be documented and
justified, and the associated in-process material or product must be quarantined.
The deviation must be reviewed and approved or rejected by quality control
personnel. Such deviations must not be approved unless quality control personnel
determine that the resulting cannabis-derived product will meet all specifications for
identity, purity, strength, and composition and is not otherwise contaminated or
adulterated.

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(d) If a deviation is rejected, the resulting in-process or finished cannabis-derived
product must be rejected, unless quality control personnel approve a treatment,
process adjustment, reprocessing, or other deviation that will ensure the cannabis-
derived product batches manufactured with the affected material will meet all
specifications for identity, purity, strength, and composition and will not be otherwise
contaminated or adulterated. Any such treatment, process adjustment, reprocessing,
or other deviation must be documented, justified, and approved by quality control
personnel.
(e) Manufacturing operations must properly identify all compounding and storage
containers, processing lines, and major equipment used during the production of a
batch of cannabis-derived product at all times to indicate their contents and, when
necessary, the phase of processing of the batch.
(f) Operations on one component, product, or batch must be physically, spatially, or
temporally separated from operations on other components, products, or batches.
(g) All necessary precautions must be taken during the manufacture of a cannabis-
derived product to prevent contamination of components and products. These
precautions include, but are not limited to:
(1) Washing or cleaning components that contain soil or other contaminants;
(2) Holding components, in-process materials, and cannabis or cannabis-derived
products appropriately;
(3) Preventing cross-contamination and mixups between contaminated
components, in-process materials, and cannabis or cannabis-derived
products and uncontaminated items;
(4) Using effective measures to protect against the inclusion of metal or other
foreign material in components or cannabis products, by, for example:
(i) Filters, strainers, or sieves;
(ii) Traps;
(iii) Magnets;
(iv) Electronic metal detectors.
Section 5.6 Manufacturing sampling requirements

(a) A representative sample of each batch or lot of component, cannabis, or cannabis-
derived product must be collected by removing and compositing portions of material
or units from throughout the containers in the batch or lot.

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(b) In addition to representative samples, other samples may be taken as appropriate
to:
(1) Monitor the quality of in-process materials during production;
(2) Examine the degree of variability of materials or products; and
(3) Investigate known or suspected non-conformances.
(c) The number of containers and the amount of material or units to be removed from
each container must be based on appropriate criteria such as:
(1) Quantity needed for testing, examination, and reserve;
(2) Past quality history of the item;
(3) Expected variability of the material or units being sampled; and
(4) Degree of confidence and precision required.
(d) The containers selected for sampling must be based on rational criteria such as
random sampling; directed sampling may be used where appropriate.
(e) Samples must be collected in accordance with the following procedures:
(1) The containers selected for sampling must be cleaned when necessary in a
manner to prevent introduction of contaminants into the component, in-
process material, cannabis or cannabis-derived product.
(2) The containers must be opened, sampled, and resealed in a manner
designed to prevent contamination of their contents and contamination of
other components, in-process materials, cannabis or cannabis-derived
product.
(3) Sterile equipment and aseptic sampling techniques must be used when
necessary.
(4) Where appropriate for the purpose of the sample and the nature of the
material being sampled, sample portions are removed from the top, middle,
and bottom of containers. Such sample portions may be composited in
forming the representative sample, or may be tested separately, as
appropriate to the purpose.
(5) Containers from which samples have been taken must be marked to indicate
that samples have been removed from them.
(f) Sample containers must be identified with the following information:
(1) Name of the item sampled;
(2) Batch, lot, or control number of the item sampled;

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(3) Container from which the sample was taken, or for samples taken directly
from the production line, the equipment line and time at which the sample was
taken, unless such information is documented separately;
(4) Date on which the sample was taken;
(5) Name of the person who collected the sample; and
(6) Quantity and unit of measure of the sample.
(g) Each sample removed from a batch or lot must be recorded in the inventory or
manufacturing batch record for the batch or lot.
(h) The quantity of sample used for each test or examination must be of sufficient size
or number to ensure the results are representative of the batch or lot.
(i) A reserve sample must be prepared from the representative sample of each batch or
lot of shelf-stable component, cannabis or cannabis-derived product.
(j) Reserve samples should consist of at least twice the quantity necessary for tests and
examinations to determine whether the shelf-stable component, cannabis or
cannabis-derived product meets established critical quality specifications. However,
where state law limits the amount of cannabis and cannabis-derived product
permitted to be kept on hand, operations may keep smaller amounts in reserve if
necessary.
(k) Reserve samples of shelf-stable components should:
(1) Be stored using an appropriate container-closure to protect against
contamination or deterioration during storage;
(2) Be stored under conditions consistent with the conditions under which the
component is stored at the manufacturing operation; and
(3) Be retained for one year past the expiration date of the last batch of cannabis-
derived product manufactured from the lot. However, where state law limits
the amount of cannabis and cannabis-derived product permitted to be kept on
hand, operations may keep reserve samples for shorter periods of time if
necessary.
(l) Reserve samples of cannabis-derived product should:
(1) Be stored using the same container-closure system in which the packaged
and labeled cannabis-derived product is distributed, or for bulk products,
using a container-closure system that provides essentially the same
characteristics to protect against contamination or deterioration as the one in
which the bulk product is distributed;
(2) Be stored under conditions consistent with the storage conditions
recommended on the product label or, if no storage conditions are
recommended on the label, under ordinary storage conditions.

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(3) Be retained for one year past the expiration date of the batch or lot. However,
where state law limits the amount of cannabis and cannabis-derived products
permitted to be kept on hand, operations may keep reserve samples for
shorter periods of time if necessary.
Section 5.7 Cannabis-derived product specifications

(a) Manufacturing operations must establish specifications for each cannabis-derived
product as follows:
(1) Manufacturing operations must establish specifications for the identity purity,
strength, and composition of each cannabis-derived product manufactured by
the operation.
(2) Manufacturing operations which receive cannabis-derived product for further
processing must establish specifications to provide sufficient assurance that
the product received is adequately identified and is consistent with the
purchase order.
(b) For each batch or lot of cannabis-derived product manufactured by the operation,
the conformance of the batch or lot to established specifications must be confirmed
as follows:
(1) For every batch or lot, or for a subset of cannabis-derived product batches or
lots identified through sound statistical sampling plan, the operation must
verify that the batch or lot meets product specifications for identity, purity,
strength, and composition, to the extent that scientifically valid test methods
exist for these specifications.
(2) In lieu of testing every established strength and composition specification for
which scientifically valid test methods exist, one or more strength and/or
composition specifications may be selected for testing, where it can be
established that testing for this reduced panel of specifications is sufficient to
ensure that the production and process control system is producing product
that meets all specifications.
(3) Where no scientifically valid test method exists for a product specification,
compliance with the specification must be established through component
and/or in-process testing, examinations, or monitoring and/or review of
manufacturing batch records.
(4) Quality control personnel must document and approve the justification for
reduced product testing under section 5.7(b)(2) or section 5.7(b)(3) of this
part.
(c) Cannabis-derived product which fails to meet its specifications must be rejected,
unless quality control personnel approve a treatment, process adjustment,
reprocessing, or other deviation that will ensure the cannabis-derived product

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batches manufactured with the affected material will meet all specifications for
identity, purity, strength, and composition, and will not be otherwise contaminated or
adulterated. Any such treatment, process adjustment, reprocessing, or other
deviation must be documented in the manufacturing batch record, justified, and
approved by quality control personnel.
(d) Any unexplained occurrence or discrepancy, and any failure of the cannabis-derived
product to meet its specifications or requirements, must be documented and
investigated. The investigation must extend to any related batches that may have
been associated with the same specific failure, discrepancy, or problem; this may
include, but is not limited to, batches of the same cannabis-derived product, other
batches processed on the same equipment or during the same time period, and
other batches produced using the same lots of components.
(e) Manufacturing operations must have written procedures describing in sufficient detail
the storage, handling, sampling, testing, and approval or rejection of cannabis and
cannabis-derived products.
Section 5.8 In-process material specifications, sampling, and testing

(a) In-process specifications must be established for any point, step, or stage in the
manufacturing protocol where control is necessary to help ensure that specifications
are met for the identity, purity, strength, and composition of the cannabis-derived
product. Such specifications may include, but are not limited to, the following as
appropriate:
(1) Weight or fill of tablets, capsules, or other units;
(2) Weight or fill variation of tablets, capsules, or other units;
(3) Hardness or friability of tablets;
(4) Disintegration time of unit dosages;
(5) Clarity, viscosity, specific gravity, total dissolved solids, or pH of solutions;
(6) Loss on drying, moisture content, or solvent residue;
(7) Microbiological characteristics; and
(8) Organoleptic characteristics.
(b) In-process specifications for such characteristics must be consistent with the
cannabis-derived product specifications.
(c) In-process materials must be sampled and tested or examined for conformance with
in-process specifications as appropriate during the production process, e.g., at
commencement or completion of significant process stages or after storage for long

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periods, and where appropriate must be approved or rejected by quality control
personnel.
(d) In-process material which fails to meet its specifications must be rejected, unless
quality control personnel approve a treatment, process adjustment, reprocessing, or
other deviation that will ensure the cannabis-derived product batches manufactured
with the affected material will meet all specifications for identity, purity, strength, and
composition and will not be otherwise contaminated or adulterated. Any such
treatment, process adjustment, reprocessing, or other deviation must be
documented in the manufacturing batch record, justified, and approved by quality
control personnel.
Section 5.9 Calculation of yield

(a) Actual yields must be determined at the conclusion of each appropriate phase of
manufacturing of the cannabis-derived product. Such calculations must either be
performed by one person and independently verified by a second person, or, if the
yield is calculated by automated equipment, be independently verified by one
person.
(b) If the percentage of theoretical yield at any process step or at the end of production
falls outside the maximum or minimum percentage of theoretical yield allowed in the
manufacturing protocol, quality control personnel must conduct an investigation of
the batch and determine, to the extent possible, the source of the discrepancy. The
deviation must be documented, explained, and approved by quality control
personnel.
SUBPART F – PACKAGING AND LABELING PROCESS CONTROLS
Section 6.1 General considerations for packaging components, including labels

(a) Cannabis to be packaged without undergoing manufacturing to a cannabis-derived
product must be received, identified, stored, handled, sampled, reviewed, and
approved or rejected as per sections 5.2 and 5.6 above.
(b) Specifications for packaging components must be established as necessary to
ensure the identity, purity, strength, and composition of the packaged products.
Packaging components that may come into contact with products must be safe and
suitable for their intended use and must not be reactive or absorptive or otherwise
affect the safety, purity, or quality of the product.

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(c) Packaging and labeling operations must establish written procedures describing in
sufficient detail the receipt, identification, storage, handling, and approval or rejection
of packaging and labeling components.
(d) Labels and other packaging components must be received and stored pending
approval as follows:
(1) Upon receipt and before acceptance, each container or grouping of
containers of packaging components must be visually examined for
appropriate labeling as to contents, container damage or broken seals, and
contamination, to determine whether the container condition may have
resulted in contamination or deterioration of the packaging components; and
(2) The supplier’s documentation for each shipment must be examined to ensure
the packaging components are consistent with what was ordered.
(3) Each container or grouping of containers for packaging components must be
identified with a distinctive code (i.e. lot or control number) for each lot in each
shipment received, which allows the lot to be traced backward to the supplier,
the date received, and the name of the component; and forward to the
product batches packaged or labeled using the lot. This code must be used in
recording the disposition of each lot.
(4) Labels and other packaging components must be stored under quarantine
until they have been examined and approved or rejected by quality control
personnel.
(e) Packaging components must be approved or rejected as follows:
(1) Each lot of packaging components must be withheld from use until the lot has
been reviewed and released for use by the quality control personnel.
(2) Compliance of the lot with established specifications must be ensured through
examination of the components received, and/or review of the supplier's
documentation.
(3) Any shipment of a packaging component that meets its specifications may be
approved and released for use for use by quality control personnel.
(4) Any packaging component that does not meet its specifications, including any
incorrect labels, must be rejected by quality control personnel, unless quality
control personnel approve a treatment or other deviation that will render the
packaging component suitable for use, and will ensure the product batches
packaged and labeled with the affected component will meet all specifications
for identity, purity, strength, composition, packaging, and labeling and will not
be otherwise contaminated or adulterated. Any such treatment or other
deviation must be documented, justified, and approved by quality control
personnel.

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(f) Use of gang-printed labeling for different products, or different strengths or net
contents of the same product, is prohibited unless the labeling from gang-printed
sheets is adequately differentiated by size, shape, or color.
Section 6.2 Packaging and/or labeling protocol

(a) Packaging and labeling operations must prepare and follow a written protocol for
each unique product to be packaged and/or labeled to assure that correct packaging
and labeling components are used for each product packaged or labeled by the
operation. Where appropriate, the packaging and/or labeling protocol may be
combined with the manufacturing protocol for the product. The protocol must:
(1) Identify the product to be packaged and/or labeled;
(2) Identify each packaging component to be used;
(3) Provide a specimen of the label and other labeling to be used, or a cross-
reference to the labeling (such as by label number and version number);
(4) Provide a statement of the acceptable maximum and minimum percentages
of theoretical yield; and
(5) Include written instructions or cross references to standard procedures for the
following:
(i) Inspection of packaging and labeling equipment before and after use to
assure that all products and packaging and labeling materials from
previous operations have been removed;
(ii) Issuance of labels and labeling to a packaging and/or labeling batch;
(iii) Careful examination of labels and labeling issued to each batch prior
to use, to ensure conformity to the labeling specified in the packaging
and/or labeling protocol;
(iv) Each packaging and/or labeling process step;
(v) Monitoring of packaging and/or labeling process steps; and
(vi) Additional applicable procedures to be followed, if any.
(b) Packaging and/or labeling protocols must be written with the intent to provide not
less than 100 percent of the labeled amount of product.
(c) The packaging and/or labeling process described in the protocol must ensure that
product specifications are consistently met.

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Section 6.3 Packaging and/or labeling batch record
(a) The packaging and/or labeling operation must prepare a packaging and/or labeling
batch record for each batch or lot of product packaged and/or labeled by the
operation. Where appropriate, the packaging and labeling batch record may be
combined with the manufacturing batch record for the batch or lot.
(b) The packaging and/or labeling batch record must:
(1) Cross-reference or reproduce the appropriate packaging and/or labeling
protocol; and
(2) Form a complete record of the packaging and/or labeling and sampling of the
batch.
(c) The packaging and/or labeling batch record must include, as applicable to the
process:
(2) Batch, lot, or control number of the product;
(3) Packaging and/or labeling batch size;
(4) For each packaging component used in production of the batch:
(i) Identity of each packaging component;
(ii) Batch, lot, or control number of each packaging component used in the
batch;
(iii) Quantity of each lot of packaging components used, including the unit
of measure.
(5) Date(s) on which, and where applicable the time(s) at which, each step of the
packaging and/or labeling protocol was performed;
(6) Identity of packaging lines and major equipment used in packaging and/or
labeling the batch;
(7) Date and time of the maintenance, cleaning, and/or sanitizing of the
packaging lines and major equipment used in packaging and labeling of the
batch, or a cross-reference to records, such as individual equipment logs,
where this information is recorded;
(8) If packaging or labeling of the batch uses equipment or instruments requiring
periodic calibration, inspection, or verification, the date and time of the last
calibration, inspection, or other verification of instruments or equipment or the
date on which such is next due; or a cross-reference to records, such as
individual equipment logs, where this information is recorded;

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(9) Statement of the actual yield and a statement regarding whether the actual
yield is within the acceptable range of the theoretical yield as per section
6.2(a)(4) at the end of packaging and/or labeling;
(10) When the actual yield falls outside the allowed limits, quality control
personnel must conduct an investigation of the batch and determine, to the
extent possible, the source of the discrepancy. The deviation must be
documented, explained, and approved by quality control personnel.
(11) Label reconciliation, as per section 6.3(f) of this part;
(12) Records of any labeling scrap or cannabis waste generated during
packaging and/or labeling of the batch;
(13) Identity of each person performing each process step in packaging and/or
labeling of the batch, including but not limited to:
(i) Inspecting labels and other packaging components to ensure suitability
and correctness prior to use in the batch;
(ii) Inspecting packaging and labeling areas before and after use;
(iii) Reconciling label issuance and usage and verifying the reconciliation
of label issuance and usage;
(iv) Examining packaged and labeled products to ensure proper labeling
and coding;
(v) Performing any other checks or verifications in packaging and/or
labeling of the batch as needed; and
(vi) Releasing the batch from one stage of packaging and/or labeling to
the next.
(d) All data in the packaging and/or labeling batch record must be recorded at the time
at which each action is performed.
(e) Printing devices located on, or associated with, production lines must be monitored
to assure that all printing conforms to the requirements of the packaging and/or
labeling protocol when used to imprint labeling or coding directly on the following:
(1) Primary packaging for the product; or
(2) Secondary packaging (e.g., a case containing several individual packages of
product).
(f) Packaging and labeling operations must reconcile the quantities of labels or labeling
issued, used, and returned to storage.
(1) Narrow limits for the labeling reconciliation must be established, based where
possible on historical operating data, for the amount of allowed variation in
the labeling reconciliation.

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(2) When a labeling reconciliation falls outside the allowed limits, quality control
personnel must conduct an investigation of the batch and determine, to the
extent possible, the source of the discrepancy. The deviation must be
documented, explained, and approved by quality control personnel.
(3) Labeling reconciliation is waived for cut or roll labels if a 100-percent
examination for correct labels is performed, either manually or by appropriate
electronic or electromechanical equipment during or after completion of
finishing operations.
(4) All excess labeling bearing batch, lot, or control numbers must be destroyed.
(5) Care must be taken when returning labeling to storage, to prevent mixups and
ensure proper identification.
(g) Representative and reserve samples of each batch or lot of retail packaged and/or
labeled product must be collected as per section 5.6 of this part.
(h) The completed packaging and/or labeling batch record for each batch or lot must be
reviewed and signed by quality control personnel to determine compliance with all
applicable specifications and other requirements of the packaging and/or labeling
protocol before a batch or lot is approved.
(i) Packaged or labeled product which fails to meet its packaging or labeling
specifications or other packaging requirements must be rejected, unless quality
control personnel approve repackaging, relabeling, or other deviation that will ensure
the product batch or lot will meet all packaging and labeling specifications and other
packaging requirements, and will not be otherwise contaminated or adulterated. Any
such repackaging, relabeling, or other deviation must be documented, justified, and
approved by quality control personnel.
Section 6.4 Label content for cannabis and cannabis-derived products

(a) Each packaged and labeled product must bear on the label of its primary packaging:
(1) Name and place of business of the manufacturer or distributor;
(3) Net quantity of contents in terms of weight, numerical count, or other
appropriate measure;
(4) A batch, lot, or control number;
(5) Either a production date or an expiration date. Products capable of supporting
the rapid and progressive growth of infectious, toxigenic, or spoilage
microorganisms must bear a "use by” date and/or a “freeze by" date. Any
shelf life or expiration period indicated on the label of an edible product must
be supported by appropriate data;

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(6) Instructions for use, including any types of compliant individuals for whom the
product is recommended, as appropriate;
(7) Appropriate warnings for use, including any types of compliant individuals for
whom the product is contraindicated, as appropriate;
(8) Instructions for appropriate storage; and
(9) Any other statements or information required by state regulators.
(b) For edible products, each product label must contain a "Product Facts" box listing
quantitative content and nutrient information relevant to the product, including, as
applicable to the product’s content:
(1) Cannabis ingredient;
(2) Cannabinoid and/or terpenoid content;
(3) Total calories and fat calories (when greater than 5 calories per serving);
(4) Total fat, saturated fat, and trans fat (when greater than 0.5 g per serving);
(5) Cholesterol (when greater than 2 mg per serving);
(6) Sodium (when greater than 5 mg per serving);
(7) Total carbohydrates (when greater than 1 g per serving);
(8) Dietary fiber (when greater than 1 g per serving);
(9) Sugars (when greater than 1 g per serving);
(10) Protein (when greater than 1 g per serving); and
(11) Vitamin A, vitamin C, calcium, and iron (when present at greater than 2% of
the recommended daily intake).
SUBPART G – HOLDING CONTROLS
Section 7.1 Identification

(a) Each container of component, packaging component, in-process material, and
product must be appropriately identified at all times with the following:
(1) Identity of the item;
(2) Batch, lot, or control number;
(3) Status (e.g., quarantined, approved, recalled, rejected).

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(b) Product packages that are held in unlabeled condition for future labeling operations
must be identified and handled to preclude mislabeling of individual containers, lots,
or batches. Identification need not be applied to each individual container but must
be sufficient to determine the identity of the product, quantity of contents, and batch,
lot, or control number of each container.
(c) Identification information required in sections 7.1(a) and (b) may be:
(1) Affixed to the individual container or to an appropriate grouping of containers;
or
(2) Assigned to the room or other defined physical location of the container(s).
Section 7.2 Storage and handling

(a) Components, packaging components, in-process materials, and products must at all
times be handled, stored, and distributed in a manner to avoid deterioration, prevent
contamination, and avoid mixups. Where necessary, appropriate conditions of
temperature, humidity, and light must be established and maintained so that the
identity, purity, strength, and composition of components, in-process materials, and
products are not affected and that adulteration is prevented.
(b) Containers of components, packaging components, in-process materials, and
product must be stored off the floor and suitably spaced to permit cleaning and
inspection.
(c) Components, in-process materials, and products that can support the rapid growth of
microorganisms of public health significance must be held in a manner that prevents
them from becoming adulterated.
(d) Labels, labeling, cannabis, cannabis-derived products, and cannabis waste must be
stored in a controlled access area.
(e) Components, packaging components, and products must be used or distributed in a
manner whereby the oldest batches or lots are used or distributed first. Deviation
from this requirement is permitted if such deviation is temporary and appropriate.
Section 7.3 Withholding materials from use or distribution

(a) Manufacturing, packaging, and labeling operations must establish and implement
written procedures for quarantine of any lot, batch, or other portion of component,
packaging component, in-process material, or product whose suitability for use or
distribution is in question, to prevent its use and distribution pending disposition by
quality control personnel. This includes:
(1) Newly received components and packaging components for use in
manufacturing, packaging and/or labeling;

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(2) Batches newly completed in production;
(3) Product returned to the operation for any reason;
(4) Components, packaging components, in-process materials, or products that
are or may be contaminated or adulterated; or
(5) Components, packaging components, in-process materials, or products that
are under investigation by quality control personnel for any other reason.
(b) Rejected components, packaging components, in-process materials, finished
product, cannabis waste, and rejected labels and labeling (including any excess
labeling bearing lot, batch, or control numbers which is not immediately destroyed
after packaging operations are complete) must be appropriately segregated,
controlled, and held in a controlled access area pending destruction or other
disposal.
(c) Cannabis waste other than cannabis and cannabis-derived product that is rejected
and returned to the vendor, and rejected labels and other labeling, must be
destroyed in a manner which prevents unauthorized use. Destruction of any
cannabis waste must be documented and witnessed by at least two workers, one of
whom must be supervisory, managerial, or quality control personnel; except that if
video surveillance is used, only one worker is necessary. Destruction may include
composting.
SUBPART H – INVENTORY AND RECORDKEEPING
Section 8.1 Materials inventory

(a) Manufacturing, packaging, labeling and holding operations must keep written
records for each shipment of component, packaging component, cannabis, and
cannabis-derived product received from another company or individual.
(b) Records must be kept of the following:
(1) Identity of the received item, as applicable to the item; and any component
number or product number if such are in use by the supplier;
(2) Supplier or vendor from which the shipment was received;
(3) Original cultivation operation, processing operation, or manufacturing
operation, if known and where applicable;
(4) The cultivation operation's, processing operation's, manufacturing operation's,
or supplier’s batch, lot, or control number, if known and where applicable;

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(5) Date of receipt; and
(6) Shipment delivery method, including where applicable the name of the
commercial or private carrier.
(c) Additionally, manufacturing, packaging, and labeling operations must keep records,
or establish cross references to other records such as manufacturing batch records,
of the following information:
(1) Batch, lot, or other control number assigned by the manufacturing, packaging,
and/or labeling operation to the shipment;
(2) Inspection, sampling, testing, and examinations performed on the batch or lot,
and the conclusions derived therefrom, as applicable to the scope of the
operation;
(3) Any treatment, reprocessing, or other deviation performed by the operation on
the batch or lot prior to use;
(4) Disposition of the batch or lot by quality control personnel, including the date
and the signature of the person responsible for approving or rejecting the
batch or lot and any treatment, reprocessing, or other deviation performed
thereon;
(5) A record of each use of the batch or lot in production, including:
(i) Quantity used, including unit of measure;
(ii) Name and batch, lot, or other control number of the product batch in
which the batch or lot is used; and
(iii) Initials of the person(s) responsible for removing from storage the
necessary quantity for use in the designated batch.
(6) A record of any portion of the batch or lot returned from production to storage,
including:
(i) Quantity returned, including unit of measure;
(ii) Name and batch, lot, or other control number of the batch or lot from
which the portion is returned; and
(iii) Initials of the persons responsible for verifying the quantity returned.
(7) A record of any portion of the batch or lot disposed of from storage, including
the quantity, unit of measure, reason, and persons responsible for measuring
the quantity.

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Section 8.2 Distributed materials
(a) Manufacturing, packaging, labeling and holding operations must keep written
records for each batch or lot of cannabis or cannabis-derived product distributed by
the operation.
(b) Records must be kept of the following:
(1) Identity of the cannabis or cannabis-derived product, and any item code or
product number if such are in use by the manufacturing, packaging, labeling,
or holding operation;
(2) A record of each distribution of the batch or lot, including:
(i) Quantity distributed, including unit of measure;
(ii) Name and address of each company or non-profit entity to which, or
individual to whom, the batch is distributed, unless a system exists to
unambiguously cross-reference the name to the corresponding
address maintained on file separately;
(iii) Shipping method by which each shipment is distributed, including
where applicable the name of the commercial or private carrier;
(iv) Initials of the persons responsible for removing from storage the
necessary quantity for each shipment. Each distribution must be
verified by a second person.
(3) A record of any portion of the batch or lot returned to storage, including:
(i) Quantity returned, including the unit of measure;
(ii) Company, non-profit entity, individual, or location from which the
portion is returned;
(iii) Shipment return method, including where applicable the name of the
commercial or private carrier;
(iv) Initials of the person(s) responsible for verifying the quantity returned;
(4) A record of any portion of the batch or lot disposed of from storage, including
the quantity, unit of measure, reason, and persons responsible for measuring
the quantity.
(c) Additionally, manufacturing, packaging, and labeling operations must keep records
or establish cross references to other records such as manufacturing batch records,
for the following:
(1) Batch, lot, or other control number assigned by the manufacturing, packaging,
and/or labeling operation to the batch or lot;

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(2) Inspection, sampling, testing, and examinations performed on the batch or lot
by the operation, and the conclusions derived therefrom;
(3) Any treatment, reprocessing, or other deviation performed on the batch or lot
by the operation prior to distribution; and
(4) Disposition of the batch or lot by quality control personnel, including the date
and the signature of the person responsible for approving the batch or lot for
distribution; and the date and the signature of the person responsible for
approving or rejecting any treatment, reprocessing, or other deviation
performed thereon.
Section 8.4 Reconciliation

(a) Records of receipt, use or distribution, return, and disposal of each batch or lot of
components, packaging components, cannabis or cannabis-derived products must
be kept chronologically, and the quantities must be recorded with an appropriate
level of precision.
(b) After each batch or lot is used or distributed, manufacturing, packaging, labeling,
and holding operations must perform a reconciliation of the quantity received into
storage against the quantity used, distributed, returned, and/or disposed. Such
calculations must be performed by one person and independently verified by a
second person.
(c) Narrow limits must be established, based where possible on historical operating
data, for the amount of allowed variation in the reconciliation.
(d) When a reconciliation falls outside the allowed limits, quality control personnel must
conduct an investigation to determine, to the extent possible, the source of the
discrepancy. The deviation must be documented, explained, and approved by
quality control personnel.
Section 8.5 Record retention

(a) Except as required in sections 8.5(b) and (c), manufacturing, packaging, labeling,
and holding operations must retain the records required by this part for a period of at
three years past date of creation of the record, or one year past the expiration date
of the related product, whichever is longer, as applicable to the operation.
(b) Product complaint records must be retained for one year past the expiration date of
the batch or lot affected, or for one year past the date of receipt of the complaint,
whichever is longer.

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(c) Records for returned products must be retained for one year past the expiration date
of the batch or lot affected, or for one year past the date of receipt of the return,
whichever is longer.
SUBPART I – COMPLAINTS, RETURNS, AND RECALLS
Section 9.1 Complaint files

(a) Manufacturing, packaging, labeling, and holding operations must establish written
procedures describing the handling of product complaints received regarding a
cannabis or cannabis-derived product.
(b) A qualified person must:
(1) Review product complaints to determine whether the product complaint
involves a possible failure of a product to meet any of its specifications, or any
other requirements, including but not limited to those specifications and other
requirements that, if not met, may result in a risk of illness or injury; and
(2) Investigate any product complaint that involves a possible failure of a product
to meet any of its specifications, or any other requirements of this part,
including but not limited to those specifications and other requirements that, if
not met, may result in a risk of illness or injury.
(c) Quality control personnel must review and approve decisions about whether to
investigate a product complaint and review and approve the findings and follow-up
action of any investigation performed.
(d) The review and investigation of the product complaint, and the review by quality
control personnel about whether to investigate a product complaint, and the findings
and follow-up action of any investigation performed, must extend to all related
batches and relevant records. Related batches may include, but are not limited to,
batches of the same product, other batches processed on the same equipment or
during the same time period, or other batches produced using the same batches or
lots of components or packaging components.
(e) A written record of the complaint and where applicable its investigation must be kept,
including:
(2) Batch, lot or other control number of the product;
(3) Date the complaint was received and the name, address, or telephone
number of the complainant, if available;
(4) Nature of the complaint including, if known, how the product was used;

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(5) Names of personnel who do the following:
(i) Review and approve the decision about whether to investigate a
product complaint;
(ii) Investigate the complaint, and
(iii) Review and approve the findings and follow-up action of any
investigation performed.
(6) Findings of the investigation and follow-up action taken when an investigation
is performed; and
(7) Response to the complainant, if applicable.
(f) Manufacturing, packaging, labeling, and holding operations must establish a
procedure for a product complaint that includes a report of an adverse event. For
purposes of this section, an adverse event is a health-related event associated with
use of a product that is undesirable, and that is unexpected or unusual. The
procedure must address whether the adverse event requires the following:
(1) Reporting to any public health authority;
(2) Reporting to the physician of record for the individual reported to have
experienced the adverse event, if known; and
(3) Product recall.
Section 9.2 Returned products

(a) Manufacturing, packaging, and/or labeling operations must establish written
procedures describing the receipt, handling, and disposition of returned cannabis or
cannabis-derived products.
(b) Returned products must be identified as such and be quarantined upon receipt.
(c) Returned product must be reviewed and approved or rejected by quality control
personnel.
(d) If the conditions under which returned product has been held, stored, or shipped
before or during its return, or if the condition of the product, its containers, or
labeling, as a result of storage or shipping, casts doubt on the identity, purity,
strength, composition, or freedom from contamination or adulteration of the product,
the returned product shall be rejected unless examination, testing, or other
investigations prove the product meets appropriate standards of identity, purity,
strength, and composition and its freedom from contamination or adulteration.
(e) If the reason a product is returned implicates associated batches, an appropriate
investigation must be conducted and must extend to all related batches and relevant
records. Related batches may include, but are not limited to, batches of the same

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product, other batches processed on the same equipment or during the same time
period, or other batches produced using the same components or packaging
components.
(f) Rejected returned product returned to the manufacturing, packaging, labeling, and
holding operation must be destroyed as per section 7.3(c).
(g) A written record must be kept of the return, and where applicable its investigation,
including:
(2) Batch, lot or other control number of the product;
(3) Date the returned product was received;
(4) Name and address from which it was returned, and the means by which it
was returned;
(5) Reason for the return;
(6) Results of any tests or examinations conducted on the returned product, or on
related batches, if any;
(7) Findings of the investigation and follow-up action taken when an investigation
is performed;
(8) Any reprocessing performed on the returned product;
(9) The ultimate disposition of the returned product, and the date of disposition;
and
(10) Names of the quality control personnel who do the following:
(i) Review the reason for the product return;
(ii) Review and approve any reprocessing, as applicable, and
(iii) Review and approve the findings and follow-up action of any
investigation performed.
Section 9.3 Recall procedures

(a) Manufacturing, packaging, labeling, and holding operations must establish a
procedure for recalling a product that has been shown to present a reasonable or
remote probability that the use of the product will cause serious adverse health
consequences or could cause temporary or medically reversible adverse health
consequences. This procedure should include:
(1) Factors which necessitate a recall;
(2) Personnel responsible for a recall; and

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(3) Notification protocols.
(b) Manufacturing, packaging, labeling, and holding operations must establish a
procedure for communicating a recall of product distributed by the operation. This
procedure should include:
(1) A mechanism to contact all customers that have, or could have, obtained the
product from the operation;
(2) A mechanism to contact the vendor that supplied the recalled product to the
operation, if applicable;
(3) Instructions for the return or destruction of any recalled product by customers;
(4) Instructions for contacting the relevant manufacturing, packaging, labeling,
and/or holding operations; and
(5) Communication and outreach via media, as necessary and appropriate.

- 48 -

GMP Cannabis

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GMP Cannabis

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What is the purpose of the document?

What is the purpose of the document?

What areas does the document provide recommendations for?

What areas does the document provide recommendations for?

Recommendations to Regulators:

Cannabis Manufacturing, Packaging,

The American Herbal Products Association (AHPA) chartered a Cannabis Committee in

Subpart A – General provisions ................................................................................... 3

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 1.1 Subject operations

Section 1.2 Other statutory provisions and regulations

Section 1.3 Definitions

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

SUBPART B – GENERAL REQUIREMENTS

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 2.2 Distribution of cannabis and cannabis-derived products

Section 2.3 Ancillary operations

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 3.2 Personnel responsibilities

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 3.3 Personnel safety

Section 3.4 Supervisor requirements

FOR DISCUSSION. Prepared for consideration by state or local regulatory

SUBPART D – PHYSICAL PLANT AND GROUNDS

Section 4.1 Design and construction

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 4.2 Sanitation requirements

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 4.3 Equipment and utensils

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

SUBPART E – MANUFACTURING PROCESS CONTROLS

Section 5.1 Manufacturing protocol

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 5.2 Manufacturing component control requirements

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 5.4 Allocation and charge-in of components

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 5.5 Process monitoring and controls during manufacturing

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 5.6 Manufacturing sampling requirements

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

FOR DISCUSSION. Prepared for consideration by state or local regulatory

Section 5.7 Cannabis-derived product specifications