Self Inspection/Assessment Checklist

Sr Particulars Details
No
1 Name of The firm Devendra Kirti pharma chem.
Pvt. Ltd.

2 Address of the Manufacturing site Plot No. N-45, M.I.D.C.Tarapur,

Industrial Area Boisar, 401501

3 Date of Inspection 07/03/2017

4 Name and Designation of the M.K.Rajpal

Inspecting Officer (s)

5 Purpose of the Inspection Routine activity checking,

cleaning, impromental changes,
New adaptation.
6 Scope of the Inspection Security, Product Quaility
Improment. Performance,
achievement.
7 References followed Office

1
 Manufacturer Details

a. Name of the firm: Devendra Kirti pharma chem. Pvt. Ltd.

b. Address (Head Quarter): 6/7, Sagar Park, Opp. Bharat Petrol Pump, Sagar Seth,
Vasai (W) – 401 201

c. Address (Manufacturing site): Devendra Kirti pharma chem. Pvt. Ltd.

Plot No. N-45, M.I.D.C. Tarapur, Industrial
Area Boisar 401501

d. Constitution of the Firm

(Enclose copy of the Pvt Ltd
constitution

e. Telephone No. of Firm: 8007862680

Head Quarter:

Manufacturing Site: Devendra Kirti pharma chem. Pvt. Ltd.

Plot No. N-45, M.I.D.C. Tarapur, Industrial
Area Boisar 401501

Contact person’s name Kushal Velaskar

and number:
f. Fax No. of the firm: Office
Head Quarter:

Site:
g. E-mail address of the firm: Devendra.kirti@yahoo.in

h. License No. of firm KD-486

(Enclose copy of the license)
License License Date of Grant Date of Validity
Form Number
25 KD/486 03/06/2017 27/05/2022

i. Categories of drugs
manufactured at the site
Categories of formulation Dosage Number of product approved
Form approved (*product list shall be enclosed as
annexure)

2
j. Whether the firm is engaged No
in contract manufacturing /
loan licensing. If yes, details
thereof.
Name of Loan License Form License Date of Date of
Licensee Number Grant Validity
-

k. Any Certificates/ approval ISO

held by the firm (ISO, WHO,
USFDA etc,)
Name of certifying agency Number & Date of Validity of
grant of certificate certificate
UK MHRA ---
WHO-GMP ---
US-FDA ---
Any other (Please specify) ---
l. Last two years turnover of the 2015-16 2016-17
firm.
Govt. Supply 35046654 64008855
Trade
Export 926800 2248350
Total (Rupees) 35973454 66257205
m. Details Of approved technical
personnel
Name of Name of Number & Date of Total
Section Person Date of Joining experience
Approval
Bulk Devendra 36/346- 18/01/201
Drugs Sankhe 2000K/31.05. 4
2000

n. List of all equipment section

wise along with capacity,
make, ID no. and MOC
o. Whether the site plan is Number & Date of approval 08/05/2012
approved.
(Enclose copy of the site plan)

3
 Checklist for Self inspection/Assessment
(Based on Schedule –M of Drugs & Cosmetics Act 1940 & Rules)

1.
GENERAL REQUIREMENTE-
1.1 Yes No Additi
Location and surroundings: onal
Comm
ent if
any
Whether the factory building is
situated and controlled to avoid risk YES
of contamination from external
environment.
Open sewage
NO
Drain
NO
Public lavatory
NO
Factories Produces disagreeable or
obnoxious NO
1. Odors
2. Fumes
NO
3. Excessive Soot
NO
4. Dust
NO
5. Smoke
NO
6. Chemical emissions
NO
7. Biological emissions
NO
If no then whether measures taken
by the firm to avoid the NO
contamination from above sources.
List of measures are taken by the yes
firm
1.2
Building and premises: -
1.2.1 Whether building has been designed
constructed and maintained to suit yes

4
 the manufacturing operations.
Whether the drugs are produced
under hygienic conditions. NO
1.2.2 Whether the building confirm to the
conditions laid down in the Factories Yes
Act, 1948
Pls attach valid factory certificate/
license issued by the competent
authority.
1.2.3 Whether the premises used for
manufacturing operations and testing YES
purpose prevents contaminations and
cross contamination.
Specify the measures taken to avoid
contamination and cross-
contamination.
1. Temperature
yes
2. Humidity
yes
3. Aseptic classes
NO
4. Environmental controls
YES
1.2.4 b) Whether adequate working space is
provided to allow orderly and logical YES
placement of
1.equipment
YES
2. materials
YES
3. movement of personnel
YES
Whether precautions are taken to
avoid risk of mix-up between different YES
categories of drugs.
What measures are taken by the firm
to avoid possibility of the Proper Labeling &
contamination specify details. Allocation of space
1.2.5 c) Whether measures taken for the
control of
i) insects
ISECTICUTTER (uv
light)
ii) birds
ISECTICUTTER
(uv light)
iii) rodents in the factory premises.
ISECTICUTTER

5
 (uv light)
1.2.6 d) What measures have been taken to
make Interior surface smooth and YES
free from cracks of
a. walls
YES
b. floors
YES
c. ceilings
so as to permit easy cleaning YES
1.2.7 e) What measures have been taken so
that the production and dispensing AHU
areas are well lighted and effectively
ventilated, with air control facilities?
1.2.7.1 Whether the air handling system
used in AHU
1. RM Stores
AHU
2. Production
AHU
3. Packing
AHU
4. QC
AHU
5. Finished Goods stores
AHU
1.2.8 f) Whether drainage system provided
which prevents back flow and entry of Yes
insects and rodents into the
premises.
1.3
Water system: -
1.3.1 Whether the unit has validated
system for treatment of water drawn YES
from
1. own premises
YES
2. any other source

Whether that water complies in

accordance with standards specified
by
1.BIS
2. Local Municipal norms.
YES
1.3.1.1 Whether bio burden in purified water
controlled / reduced. NO
List of measures
1.3.2 Whether water tank are cleaned
YES

6
 periodically
Whether records are maintained
List of documents YES
1.Cleaning Schedule
YES
2.Cleaning check list
YES
3.Cleaning solution preparation
YES
whether water distribution system is
sanitized to control microbial NO
contaminations.
1.4
Disposal of waste: -

1.4.1 Whether company has provided the

system of disposal of YES
1.sewage
YES
2.effluents
YES
a. solid
YES
b. liquid
YES
c. gas
---
If not whether alternative
arrangement for the same is
provided.
1.4.2 Whether provision for disposal of bio-
medical waste made as per the YES YES
provisions of the Bio Medical Waste
(Management and Handling) Rules
1996.
If not whether alternative
arrangement for the same is
provided.
2.
Warehousing Area: -

2.1 Whether adequate areas have been

allocated for warehousing of YES
1. Raw Materials
YES
2. Intermediates
YES
3.Packaging Material
YES

7
 4.products in quarantine
YES
5. finish products
YES
6. rejected

7. returned products.

whether these areas are

1. Marked Yes

2. Segregated.

2.2 Whether good storage conditions

maintained in the warehousing area. YES
Whether area is maintained for
YES
1.clean and dry conditions
YES
2. acceptable temperature limits
YES
Whether the storage arrangement
provided for materials which sensitive
to
1. temperature,
NO
2. 2.humidity and
YES
3. light
YES
Whether the parameters for above
controls are monitored. NO
Whether cold room or deep freezers
provided for storage of goods? NO
If yes, how the temperature is
monitored ---
2.2.1 Whether proper racks, bins and
platforms have been provided for the YES
storage.
2.3 Whether receiving bays are
maintained to protect in coming YES
materials.
Specify the list of measures adopted
to protect the incoming materials YES
Whether dispatch bays are
maintained to protect out going YES
materials.
Specify the list of measures adopted
to protect the outgoing materials

8
2.3.1 Whether incoming materials before
entry into the plant are subjected to YES
1.Any special treatment
YES
2.Dedusting
YES
3. Cleaning
YES
Specify the list of measures adopted
to clean the incoming materials Vaccum
Cleanear,C
loth
Brooms,
Detol etc.
2.4 Whether quarantined materials are
segregated from other materials yes yes
Whether quarantine area used for
storage of any other material No
Whether access to quarantined area
is restricted. No
2.5 Whether separate sampling area for
active Raw Materials and Excipients No
is provided and maintained.
Whether separate entry is provided
for sampling of raw material Yes
Whether reversed LAF is provided in
the sampling area
Whether validation of environmental
controls in the sampling area is done No
Whether log book for sampling booth
is maintained Yes
Whether the arrangements provided
to sample the primary packaging yes
materials foils, bottles, etc
2.5.1 Whether sampling plan is prepared.
Yes
What type of sampling tools are used
Sampeling
rod ,
pippets
,hand
glows,spoo
ns,mask,s
afety
goggles.bot
tles, poly
bags etc.

9
 Whether SOP adopted for the
cleaning of sampling tools. yes
Whether log book for sampling tools
is maintained. yes
Whether containers are cleaned as
per SOP before and after sampling. yes
Specify the name & designations of
the responsible persons for sampling. Rajaram
Bohere
Q.C. Incharge
2.5.2 Whether precautions are taken
during sampling of photosensitive, (Nitrogen
hygroscopic materials? required
for
hygroscopi
c
materials)
2.6 Whether provisions have been made
for segregated storage of materials or yes
products which are
1.rejected,

2.recalled or

3.returned.

Whether precautions has been taken

to avoid mix-up of these materials Yes .Red
net is
covered on
rejected
/recalled
or returned
material
How the access to these areas is are
restricted.
Whether the records for these
materials are maintained.
2.7 Whether separate area is provided for

1. Highly hazardous material

NA
2.Poisonous & explosive materials
Yes
3.Narcotic & psychotropic substances
NA
How these areas are safe and secure.

10
 Is there certification from competent
authority for handling of explosives For poison
etc. If any. Pls attach the certificate substance
issued by the competent authority.
2.8 Whether printed secondary packaging
materials are stored in safe, separate yes
and secure manner.
2.9 Whether separate entry for man &
material is provided in to dispensing
area.
Whether reverse LAF have been
provided . No
Whether back ground clean air
supply is provided in dispensing area. yes
Whether pressure differential is
maintained between the dispensing yes
and adjacent areas.
Whether periodic validation of this
area is carried out. No
2.9.1 Whether dispensing tools are cleaned,
dried and maintained as per current yes
SOP.
Whether containers are cleaned
before and after dispensing. yes
Who carries out dispensing
yes
2.10 Whether sampling of sterile materials
is carried out in controlled area. No
Whether proper precaution is taken
for handling of material. yes
2.11 Whether steps are taken against
spillage, breakage and leakage of yes
containers?
2.12 Which substance is used for pest
control in warehousing area. yes
3.
Production Area: -

3.1 Whether the design of manufacturing

area is such that which allow uni- yes
flow and logical sequence of
operations so as to prevent product
contamination/ mix ups.
Is there any criss cross of flow of
materials and men.
Whether non storage areas used for
storage of any material.

11
 Whether separate IPQC lab provided
in mfg. area no
Whether manufacturing area
provided with proper air filtration production
system.
Whether the records for
environmental controls are yes
maintained.
Whether environmental controls are
validated periodically. yes
3.2 Whether separate dedicated and self-
contained facilities have been NA
provided for the production of
sensitive pharmaceutical product like
1.Penicillin,
------
2.Biological preparation
-----
3. Beta lactam,
------
4.Sex Hormones and
-----
5. Cytotoxic substances.
-----
If yes pls explain how and attach
copy of plan of premises of each ----
category of drug.
3.3 Whether separate and dedicated area
is provided for storage of dirty, NO
washed and cleaned equipment
parts, tool room, in process storage
areas etc.
3.4 Whether service lines are identified
by colors for nature of supply and NO
direction of the flow.like
1.pipe work,
NO
2.electrical fittings,
NO
3. ventilation openings etc.
NO
Whether service lines in production
areas are through service pendants. YES
If not, how they are placed so as to
avoid accumulation of dust. -----
4.
Ancillary areas: -

12
4.1 Whether the rest and refreshment
rooms are separate and not leading YES
directly to the manufacturing and
warehouse areas.
4.2 Are there general change rooms in
plant?
Are toilets, change room separate
from mfg. Area? YES
Specify number of washing station &
toilets provided for number of users. YES
Whether change facilities separated
for both sexes. YES
How many sets of protective
garments provided for each personnel YES
entering production area.
Is there in house general laundry for
garment washing / cleaning? YES
If not how garments washing are
carried out and monitored. YES
4.3 Whether maintenance workshop is
separate and away from production. YES
4.4 Whether animals for production or
testing are housed in the facility NO

if yes,
Whether areas housing animals are
isolated from other areas. ------
Whether the provision of air
conditioned and ventilation system ------
for the animal house provided.
Whether Controlled air system is
provided in the area where --------
quarantined, under test and tested
animals housed.
Whether animal carcass are disposed
as per CPCSEA.
5.
Quality Control Area: -
5.1 Whether QC area is independent of
production area. YES
Whether QC carries out its own:
YES
 physico-chemical testing,
YES
 biological testing,
NO
 microbiological testing &
YES

13
 sterility testing and
 Instrumental testing.
YES
Whether firm is outsourcing testing.
YES
If yes
Names of the testing laboratories
contacted or approved. INVOCHE
M,
THERMOL
AB
Please give list of test currently
outsourced. For
IR,HPLC &
GC
Are there safety installation in the
laboratory such as YES
1.shower,
YES
2.eye washer,
YES
3.fire extinguisher
YES
Whether separate area for humidity
chambers for stability studies. YES
Pls attach stability calendar.
YES
5.2 Whether the arrangement provided
for handling and storage of YES
1.test samples,
YES
2.retained samples,

3.reference standards
----
4. cultures,
------
5. reagents.
YES
Whether separate area for storage of
reagents and glassware provided. YES
Whether separate records room is
provided. YES
5.2.1 Whether hazardous or poisonous
materials are stored and handled YES
separately
5.3 Whether environmental conditions
are maintained during the course of YES
storage and testing of samples.

14
 Whether separate washing and drying
area provided. YES
5.3.1 Which grades of glassware are used
in assay procedures? borosil
5.3.2 Whether separate AHU's with
HEPA filter arrangement. are NO
provided for
1.biological,
NO
2. microbiological
NO
3.radio iso-topes testing areas
NO
5.4 Whether separate areas provided for
sterility testing within microbiology NO
lab.
Whether support areas are under
AHU. yes
Whether double door autoclave
provided for sterilization of materials. NO
Whether entry to the sterility area is
through three air lock systems. NO
What is the air class of these testing
areas NO
Whether pressure difference is
maintained in these areas? NO
Whether suitable workbenches are
provided in these areas for testing? YES
When was the last filter integrity tests
performed on HEPA filters. NO
whether waste (cultures etc) disposed
of as per the written procedures NO
Whether in case of antibiotic potency
testing, statistical proof of the NO
determination of potency and validity
of the test carried out.
6.
Personnel: -

6.1 Whether the manufacturing and

testing of drugs is conducted under YES
approved technical staff.
6.2 Whether head of Q.C. is independent
of manufacturing unit YES
6.3 Name, qualification and experience of
the personnel responsible for Quality
Assurance function.

15
6.4 Whether responsibilities for
production and QC laid down and YES
followed.
6.5 Whether adequate number of
personnel employed in direct YES
proportion to the work load.
6.6 Whether firm prepared policy on
training of personnel at various YES
levels?
7.
Health, clothing and sanitation of
workers: -

7.1 Whether personnel handling Beta

lactam antibiotics are tested for NO
penicillin sensitivity before
employment.
7.2 Whether personnel involved in
handling of sex hormones, cytotoxic NO
and other portent drugs are
periodically examined for adverse
effect.
7.3 Whether all personnel prior to
employment have undergone medical YES
examination including
1. eye examination
YES
2. free from Tuberculosis,
YES
3. free from skin diseases
YES
4. free from other communicable
or contagious diseases YES
Whether there is a SOP for medical
examination. YES
Pls. give name and qualification of
contracted medical officer for medical Dr Uttam
examination. Babar
Whether investigational reports, films
of X rays etc. preserved. Yes
Whether records of such medical
examination are maintained thereof Yes
7.4 Whether all personnel are trained to
ensure high level of personal hygiene. YES
7.5 Whether proper uniforms and
adequate facilities for personal YES
cleanliness are provided.

16
 Specify nature and type of dress used
by the personnel in various areas of YES
operation.
How many dress/footwear have been
provided to each personnel. YES
Whether cross over bench is in place
in the change room and YES
If so whether it rule out the
possibility of entering dust particle to NO
the clean side.
Whether arrangements provided for
cleaning of outside dust and dirt from YES
foot
Whether hands are disinfected before
entering the production area YES
Whether for sterile garments in house
clean laundry has been provided. NO
8.
Manufacturing Operations and
Controls: -

8.1 Whether the contents of all vessels

and containers used in manufacture YES
and storage is conspicuously labeled
with
1.name of the products.
YES
2.Batch no,
YES
3.Batch Size,
YES
4.stage of manufacture
YES
5. signature of technical staff.
YES
8.1.1 Whether the products not prepared
under aseptic conditions are free YES
from pathogens like Salmonella,
Escherichia coli, Pyocyanea etc.
If yes, pls give brief account of
8.1.2 measures taken to assure freedom YES
from pathogens.
8.2
Precautions against mix-up and cross-
contamination: -

8.2.1 Whether proper arrangements of

following have been provided to YES

17
 prevent mix-up and cross-
contamination in manufacturing
area.
1.AHU,
YES
2.pressure differential,
YES
3.segregation,
YES
4.status labeling
YES
Pls specify the areas of dust
generation YES
Pls specify the mechanism involved in
controlling the dust. YES
Do all the areas have their own
independent air locks separately for YES
men and material entry.
What criteria of pressure differential
have been set for production v/s YES
adjoining areas.
Whether various operations are
carried out in segregated areas.
8.2.2 Whether processing of sensitive drugs
like Beta lactum Antibiotics and Sex
Hormones is done in segregated areas
Whether independent AHU and
proper pressure differentials are YES
provided
Whether demonstration of effective
segregation of these areas with YES
records are provided.
Whether measures has been taken to
prevent contamination of products
with
- Beta Lactum
no
- Antibiotics,
no
- Sex harmons
no
- cyto toxic substances
no
8.2.3 Whether measures has been taken to
prevent mix-ups during various YES
stages of production.
Whether equipments use for
production are labeled with their YES

18
 current status.
8.2.4 & Whether packaging lines are
5 independent and adequately YES
segregated.
Whether records of line clearance is
maintained according to appropriate YES
checklist.
8.2.6 Whether separate carton coding area
has been provided or online carton
coding is performed
Whether carton coding procedure is
controlled.
8.2.7 Whether temperature, humidity and
air filtration are controlled in the YES
areas where raw material and/or
products are exposed and handled.
8.2.8 Whether access of authorized persons
to manufacturing areas including YES
packaging is controlled.
Whether separate gowning provision
is follows before entering into the YES
production area.
8.2.9 Whether segregated secured areas for
recall or rejected materials or for YES
such material which are to be
processed or recovered are provided.
9.
Sanitation in the Manufacturing
areas:-

9.1 Whether cleaning procedure is

validated. YES
9.2 Whether the manufacturing areas are
used as the general thoroughfare
when storage of materials not under
process.
9.3 Whether a routine sanitation program
is in place.
9.4 Whether location facilitates cleaning
of equipment as well as the cleaning
of the areas in which they are
installed.
9.5 Whether production area is
adequately lit. If yes. YES
Please give lux levels provided in

19
 1. production,
YES
2. visual inspection and
YES
3. other areas.
YES
10
Raw Materials: -

10.1 Whether the hard copies of records of

Raw Materials are maintained as per YES
schedule-U.
10.2 Please specify the procedures
followed receiving and processing of YES
in-coming materials (Starting
materials and packing material).
Whether first in / first out or first
expiry principal has been adopted. YES
10.3 Whether they are labeled and stored
as per their status – Under Test,
Approved and Rejected
10.4 Whether incoming materials are
purchased from approved sources. YES
What is the procedure for approving
the source for incoming materials. YES
Whether the raw materials are
directly purchased from the YES
manufacturers.
Whether list of approved vendors is
available to the user. YES
10.4 How damaged containers are
identified recorded and segregated. office
10.5 Whether each batch of a consignment
is considered for sampling, testing YES
and release.
Whether all the containers of each
batch of starting materials is sampled YES
for identification test.
10.6 Whether labels of raw material in the
storage area have information like YES
(a) designated name of the product
and the internal code reference, YES
where applicable, and analytical
reference number;
(b) manufacturer’s name, address
and batch number; yes
(c) the status of the contents (e.g.
quarantine, under test, released, YES

20
 approved, rejected); and
(d) the manufacturing date, expiry
date and re-test date. YES
10.7 Whether separate areas are provided
for under test, approved and rejected YES
materials.
Whether control on temperature and
humidity conditions, wherever YES
necessary, maintained in these
storage areas.
10.8 Whether the containers from which
samples have been drawn labeled. YES
Pls specify the procedure for labeling
these containers. YES
10.9 Please specify the procedures by
which it is ensured that the raw YES
materials which has been released by
the Quality Control Department and
which are within their shelf life are
going to be used in the product.
Whether raw materials released after
the complete analysis as per YES
specifications.
10.10 How materials are stacked in the
Stores i.e on Pallets, racks etc. YES
11
Equipment: -

11.1 Whether the equipments are designed

aiming to
1. minimize risk of error and
YES
2. permit effective cleaning in
order to avoid cross YES
contamination, build up of
dust.
Whether all equipment are provided
with log book. YES
Please specify the procedures to clean
the equipment after each batch yes
production.
Whether validity period for use after
the cleaning of equipment is
specified.
Whether separate area is provided for
storage of cleaned equipments. Yes

21
 Whether separate area is provided for
storage of machine parts etc. Yes
11.2 Whether balances and other
measuring equipments with Yes
appropriate range are available in the
Raw Material stores and they are
calibrated in accordance with SOP
maintained.
Whether calibration records of the
balances are maintained. Yes
Whether calibration schedule of the
balances are provided. Yes
11.3 Whether appropriate material of
construction of contact parts of the
production equipments is adopted.
Please specify,
11.4 Whether appropriate grade of
lubricants are used in the equipment no
Specify the quality and control
reference No. of these lubricants. no
11.5 Specify the procedures to remove
defective equipments from production
areas.
Whether schedule of preventive
maintenance of the equipments is Yes
available.
12
Documentation and Records: -

12.1 Whether the documents are designed,

prepared, reviewed and controlled to Yes
provide an audit trail.
Whether documents are approved
12.1.1 Yes
signed and dated by appropriate and
authorized person.
12.2 Whether documents specify title,
nature and purpose. Yes
Whether documents are regularly
12.3 reviewed and kept up to date. Yes
If yes. Please specify review period.
12.4 Whether the records are made at the
time of each operation in such a way Yes
that all significant activities
concerning to the production are
traceable.
12.5 Whether data is recorded by
electronic data processing system or Manual

22
 by other means. If by electronic data
processing system then how access is
controlled to enter, modify etc. the
data.
Whether master formula and detailed
operating procedures are maintained
as hard copy.
Who is responsible for maintenance
of these records.
Whether the procedure and SOP for
change control is available.
13
Labels and Other Printed Materials:

13.1 Whether the printing is in bright

colour and legible on labels and other Yes
printed materials.
Whether SOP is prepared for the
approval of printed labels (art work) Yes
Whether colour coding system is used
to indicate the status of a product Yes
and equipment.
Please specify,
13.2 Whether printed packaging materials,
product leaflets etc. are stored No.
separately.
13.3 Whether the procedure is evolved to
control labels, cartons, boxes, No.
circulars, inserts and leaflets.
13.4 Whether the samples from the bulk
are drawn tested, approved and yes
released prior to packaging and
labeling.
13.5 Whether records of receipt of all
labeling and packaging materials are yes
maintained.
Whether re-conciliation of used
packaging materials is maintained.
Whether unused packaging materials
return to the store or destroyed.
Whether returned/unused packaging
material like foils is controlled so as NA
to prevent mix-up.
13.6 whether reference labels are
maintained. Yes
14
Quality Assurance: -

23
14.1 Whether comprehensive quality
(a) assurance system maintained by the
firm Inter-alia to cover
- deviation,

- reporting,

- investigation

- change control.

(b) Whether the arrangements provided

to ensure that correct starting and production
packaging materials are used for
manufacture.
(c) Whether the mechanism by which all
control like IPQC Calibration, Yes
Validation etc. are ensured.
(d) Whether the procedure available to
ensure that the finished product has Yes
been correctly processed and checked
in accordance with the established
procedures.
Whether the batch record and
analytical data reviewed prior to Yes
batch release
(e) Whether the Pharmaceuticals
products released for sale by Yes
authorized person.
Pls specify the name & designation of
the person responsible for review of
records prior to batch release.
15
Self Inspection and Quality Audit: -

15.1 Whether the firm has constituted a

self inspection team supplemented Yes
with a quality audit procedure to
evaluate that GMP is being followed.
Whether the periodic Self Inspection
and Quality Audit are carried out as YES
per schedule.
Whether the system of monitoring,
evaluation of self inspection is YES
available.
Whether the conclusion and
recommended correcting actions are YES

24
 followed and adopted.
15.2 What is the frequency of self-
inspection. `In peocess
15.3 Is there any proforma for carrying out
the self-inspection.
Please indicate the date of last self-
inspection.
16
Quality Control System: -

16.1 to Whether the independent quality

16.3 control system is provided. YES
Whether the reference standards are
stored, evaluated and maintained. YES
Whether the reference standard and
reference impurities procured from YES
the authentic sources.
Whether the procedures of
preparation of working standard from YES
the reference standards is available.
16.4 & Whether SOPs available for
16.5
- sampling,
YES
- inspecting,
YES
- testing of Raw Materials,
YES
- testing of Finish products,
YES
- testing of Packing Materials
YES
- monitoring environmental
conditions YES
Whether approved specifications for
different materials, products, YES
reagents, solvents including test of
identity content, purity and quality
available.
16.7 Whether the reference samples from
each batch of the products are YES
maintained.
16.6 & Who releases batch of the products
16.8 for sale or supply. YES
16.9
Whether there is check list for release
of a batch. YES
Please specify current SOP No. for

25
 batch release.
Whether the sampling procedures
from various stages of production are YES
available.
Whether the procedure is available to
ensure that the sample collected are YES
representative of the whole batch.
16.10 Whether the procedures for carrying
16.11 out the stability studies is available. YES YES
Whether the stability studies are
carried out as per written procedure. YES YES
How many stability chambers have
been provided. TWO
Whether shelf life is assigned to a
product as per written procedure. YES
Whether records of stability studies
are maintained. YES
Whether the stability calendar is
available. YES
Whether the procedure for complaints
investigation is available with respect YES
to stability of the products.
16.12 Whether instruments are calibrated
at specified interval. YES
Whether the testing procedure
validated before they are adopted for YES
routine testing.
Whether the validation procedures
are documented YES
16.13 Whether specifications are available.
For
- raw materials,
YES
- intermediates
YES
- final products and
YES
- packaging materials
YES
Whether periodic revision of these
specifications are carried out. YES
Whether the Standard Test
Procedures being maintained by the YES
firm.
16.14 Which pharmacopoeias in original are
available in the plant. YES
17
Specifications: -

26
17.1 Whether specification of raw material
include. YES
(a) the designated name and internal
code reference; YES
(b) reference, if any, to a
pharmacopoeial monograph; YES
(c) qualitative and quantitative
requirements with acceptance limits; YES
(d) name and address of
manufacturer or supplier and original Yes
manufacturer of the material;
(e) specimen of printed material;

(f) directions for sampling and testing

or reference to procedures; YES
(g) storage conditions; and
YES
(h) Maximum period of storage before
re-testing. One year
Whether specification of finished
product include yes
(a) the designated name of the
product and the code reference; yes
(b) the formula or a reference to the
formula and the pharmacopoeial yes
reference;
(c) directions for sampling and testing
or a reference to procedures; yes
(d) a description of the dosage form
and package details;
(e) the qualitative and quantitative
requirements, with the acceptance yes
limits for release;
(f) the storage conditions and
precautions, where applicable, and yes
(g) the shelf-life.
yes
17.2 Whether the container and closures
meet the pharmacopial specifications. yes
Whether second hand or used
containers and closures used. no
18
Master Formula Records: -
Whether the procedure available for
preparation, authorization and In Process
control of master formula records.

27
Whether head of production, quality
control and quality assurance unit
endorse this documents.
Whether master formula is batch size
& quantity specific.
Whether all products have master
formula containing.
(a) the name of the product together
with product reference code relating
to its specifications;
(b) the patent or proprietary name of
the product along with the generic
name, a description of the dosage
form, strength, composition of the
product and batch size;
(c) name, quantity, and reference
number of all the starting materials
to be used. Mention
shall be made of any substance that
may ‘disappear’ in the course of
processing.
(d) a statement of the expected final
yield with the acceptable limits, and
of relevant intermediate yields, where
applicable.
(e) a statement of the processing
location and the principal equipment
to be used.
(f) the methods, or reference to the
methods, to be used for preparing the
critical equipments including
cleaning, assembling, calibrating,
sterilizing;
(g) detailed stepwise processing
instructions and the time taken for yes
each step;
(h) the instructions for in-process
control with their limits; yse
(i) the requirements for storage
conditions of the products, including yes
the container, labeling and special
storage conditions where applicable;
(j) any special precautions to be
observed; yes
(k) packing details and specimen
labels.

28
19 &
20 Packaging Records: -
Whether authorized packaging
instructions for each products, pack yes
size and type are maintained .
Whether following are included in the
packaging instructions. yes
(a) Name of the product;
yes
(b) description of the dosage form,
strength and composition; yes
(c) the pack size expressed in terms of
the number of doses, weight or yes
volume of the product in the final
container;
(d) complete list of all the packaging
materials required for a standard yes
batch size, including quantities, sizes
and types with the code or reference
number relating to the specifications
of each packaging material.;
(e) reproduction of the relevant
printed packaging materials and yes
specimens indicating where batch
number and expiry date of the
product have been applied;
(f) special precautions to be observed,
including a careful examination of the yes
area and equipment in order to
ascertain the line clearance before
the operations begin.
(g) description of the packaging
operation, including any significant yes
subsidiary operations and equipment
to be used;
(h) details of in-process controls with
instructions for sampling and yes
acceptance; and
(i) Re-cancellation after completion of
the packing and labeling operation. yes
(j) Whether line clearance records are
part of batch packing records. yes
21
Batch Processing Records
(BPR)
21.1 Whether BPR are based on current
master formula record. yes

29
 Whether the procedure is evolved to
avoid transcription errors in BPR yes
Whether the Batch Processing
Records for each product on the basis yes
of currently approved master formula
is being maintained.
Whether following information are
recorded in BPR
(a) the name of the product,
Yes
(b) the number of the batch being
manufactured, Yes
(c) dates and time of commencement,
significant intermediate stages and Yes
completion of production.
(d) initials of the operator of different
significant steps of production and Yes
where appropriate, of the person who
checked each of these operations,
(e) the batch number and/or
analytical control number as well as Yes
the quantities of each starting
material actually weighed,
(f) any relevant processing operation
or event and major equipment used, Yes
(g) a record of the in-process controls Yes
and the initials of the person(s)
carrying them out,
and the results obtained,
(h) the amount of product obtained Yes
after different
and critical stages of manufacture
(yield),
(i) comments or explanations for Yes
significant deviations from the
expected yield limits shall be given,
(j) notes on special problems
including details, with signed
authorization, for any deviation from
the Master Formula,
(k) Addition of any recovered or
reprocessed material with reference
to recovery or reprocessing stages.
Specify the procedures for all the
entries made in BPR’s.
22
Standard Operating Procedure and

30
 Records: -
22.1 toWhether SOPs and records are being
22.5 maintained and complied for the yes
following.
SOP for receipt of in coming material
(a) SOP for Internal labelling,
quarantine, storage, packaging yes
material and other materials
(b) SOP for each instrument and
Equipment yes
(c) SOP for sampling
yes
(d) SOP for batch numbering
yes
(e) SOP for testing
yes
(f) SOP for equipment assembly and
validation
(g) SOP for Analytical apparatus and
calibration yes
(h) SOP for maintenance, cleaning Yes
and sanitation
(i) SOP for training and hygiene for Yes
the personal
(j) SOP for retaining reference Yes
Samples
(k) SOP for handling, re-processing
and recoveries Yes
(l) SOP for distribution of the
product yes
(m) SOP for warehousing of
products. yes
Whether applicable SOPs are
available in each area where they are yes
required.
Whether recording formats are
referred in SOP. yes
Is there SOP for writing an SOP.
yes
23 Reference Samples
yes
23.1 & Whether the procedures is available
2 for collection of reference samples of yes
active ingredients and finished
formulations
Whether the facilities provided for
storage and maintenance. yes

31
24 Reprocessing and Recoveries
QA
24.1 – Whether reprocessed batch is
24.3 subjected to stability evaluation. yes
Whether the recoveries are added into
the subsequent batches. If yes specify QA
the procedures.
25 Distribution records
QA
Whether pre dispatch inspections are
carried out before release. YES
Whether periodic audits of
distribution center are carried out to QA
access warehousing practices
Whether distribution records are part
of the batch record QA
If not how batch wise distribution
record up to retail levels are QA
maintained.
Whether instruction for warehousing
and stocking of products like LVPs, QA
Heat sensitive etc are available in
store.
26
Validation and Process Validation: -
26.1 to Whether the validation policy of the
26.5 company is available.
Whether validation master plan has In Process
been prepared.
Whether validation studies of Yes
processing, testing and cleaning
procedures are conducted as per pre
defined protocol.
Whether the records and conclusion Yes
of such validation studies are
prepared and maintained.
Whether master formula is based on
approved process validation.
Whether significant changes to the Yes
manufacturing process equipments
material etc are controlled.
Whether DQ,IQ,OQ & PQ are in place Yes
for all major equipment and facility.
Whether qualification records of all Yes
utilities and major equipments are
available.

32
27
Product Recalls: -
27.1 Whether the product recall system
to followed by the firm.
27.6 Whether procedure is evolved for
promptly recall operation at the level
of each distribution channel up-to
the retail level .
Whether there is a SOP for recall of Yes
products clearly defining
responsibility, procedure, reporting,
re-conciliation etc.
28
Complaints and Adverse Reactions: -
28.1 Whether the review system for
complaints concerning the quality of Yes
products is available.
Whether records of complaint and Yes
adverse reactions maintained.
Whether reports of serious drugs
reaction with comments and
documents immediately sent to
Licensing Authority
Is there any criteria for action to be Yes
taken on the basis of nature of
complaint / adverse drug reaction.
29
Site Master file: -
Whether all the relevant information
is included in the site master file.
Whether quality policy is included in
the site master file.

33
 Checklist pertaining to Specific Dosage form
PART-IA
(Specific requirements for manufacture of Sterile products, Parenterals
preparations (Small Volume Injectable Large Volume Parenterals) and
Sterile ophthalmic preparations)
Requirements Yes No Additional Comments
/specific observations
noted with examples
1. Whether dampness, dirt and
darkness is visible in the
facility.
2. Building and Civil Works

2.1 Whether the building is

devoid of cracks especially in
the Aseptic solutions
preparation rooms, Filling
rooms, Sealing rooms
2.2 Are the location of services
like water, steam, gases etc.
are such that the servicing or
repairs can be carried out
without any threat to the
integrity of the facility
2.3 Whether water lines pose any
threat of leakage to the
aseptic area
2.4 Whether the manufacturing
areas clearly separated into
Support Areas (washing and
component preparation areas,
storage areas etc.)
Preparation areas (bulk
manufacturing areas, non
aseptic blending areas etc)
Change areas and Aseptic
areas
2.5 Whether de-cartooning areas
to remove outer cardboard
wrappings of primary
packaging materials
segregated from the washing
areas
2.6 Whether particle shedding
materials like wooden pallets,
fiber board drums,
cardboards etc taken into the

34
 preparation areas etc
2.7a Whether in the aseptic areas:
Walls, floors and ceiling are
- Impervious
- Non-shedding
- Non-cracking
- Coved at wall and
ceiling junction
2.7b Whether the walls are flat,
smooth and devoid of
recesses
2.7c Whether the surface joints
like electric sockets, gas
points flushed with walls

2.7d Whether the ceiling is solid

and the joints are properly
sealed.
2.7eAre the air grills and lights
flushed with the walls
2.7f Are the grade A & B areas
devoid of sinks and drains
2.7g Are the doors and windows
made up of non-shedding
materials
2.7h Whether doors open towards
higher pressure areas and
close automatically due to air
pressure
2.7i In case fire escapes are
provided, whether they are
suitably fastened to
the walls without gaps
2.7j Whether the quality of the
furniture used is smooth &
washable and made of
stainless steel, or of any
other suitable material
other than wood
2.8 Whether the Manufacturing
and support areas have the
same quality of civil structure
as desired for aseptic areas
except the environmental

35
 standards which may vary in
the critical areas
2.9 Is the change rooms entrance
provided with air locks before
entry to the sterile product
manufacturing areas and then
to the aseptic areas.

2.10 Are the change rooms to the

aseptic areas clearly
demarcated like ‘black’, ‘gray’
and ‘white’ with different
levels of activity and air
cleanliness?
2.11 Are the sinks and drains in
the first change rooms (un-
classified) kept clean all the
time
2.12 Do the specially designed
drains are periodically
monitored to check for
pathogenic micro-organisms
2.13 Whether an appropriate inter-
locking system with visual
and/or audible warning
system installed to prevent the
opening of more than one door
at a time.

2.14 Do the aseptic and non-

aseptic areas provided with
intercom telephones or speak
phones for communication
purposes
2.15 Whether the aseptic areas and
outside areas provided with
suitable air- locks or pass
boxes with suitable
interlocking arrangements for
material transfer

2.16 Are the rest rooms, tea room,

canteen and toilets outside
the sterile manufacturing area

2.17 Are the animal houses outside

and away from the sterile

36
 product manufacturing area
with separate AHU.

3 Air Handling System (Central

Air Conditioning)
3.1 Whether the Air Handling
Units for sterile product
manufacturing area separate
from those for other areas
3.2 Give the Background Grade of
air for following critical areas:
 Aseptic filling area

 Sterilized components
unloading area for
aseptic filling
preparations.
 Sterilized components
unloading area for
terminally sterilized
products.
 Filling room of
terminally sterilized
products.
 Batch manufacturing
area for aseptic filling
preparations.
 Batch manufacturing
area for terminally
sterilized products.
 Component washing
and preparation area.
 Final change room
(Aseptic Area)
3.3 Whether Aseptic filling area,
sterilized component
unloading area and changes
rooms conforming to Grade B,
C and D have separate Air
Handling Units.

3.4 Are the filter configuration in

the air handling system
suitably designed to achieve
the Grade A, B, C and D of air
as per designated classified

37
 areas.
3.5 Whether the types of
Operations to be carried out in
the various Grades for Aseptic
Preparations are as under:
a) Grade Type of Operation
Aseptic preparation & filling
b) Aseptic Solution preparation
to be filtered
d) Handling of components after
Washing
3.6 Whether for aseptically filled
products the filling room meet
Grade B conditions at rest,
unmanned within a period of
about 30 minutes of the
personnel leaving the room
after completion of operations
3.7 Are the filling operations
undertaken in Grade A
conditions and demonstrated
under working of simulated
conditions
3.8 Whether the filling room
meets Grade C conditions at
rest in case of terminally
sterilized products and these
conditions obtainable within a
period of about 30 minutes of
the personnel leaving the
room after completion of the
operations
3.9 Whether the manufacturing
and component preparation
areas for terminally sterilized
products meet Grade C
conditions
3.10 Whether the washed
components and vessels for
terminally sterilized products
protected with Grade C
background or if necessary
under LAF station.

3.11 Whether the number of air

changes in Grade B and
Grade C areas are more than

38
 20 per hour.
3.12 Whether the Grade A Laminar
Air Flow stations meet the
criteria of air flow of 0.3 meter
per second in case of vertical
and that of 0.45 meter per
second in case of horizontal
flows +/- 20 %

3.13 Whether the differential

pressure between areas of
different environmental
standards meets the
requirements (at least 15
Pascal/ 0.06 inches/ 1.5 mm
water gauge)

3.14 Whether suitable manometers

/ gauges installed for
measurement and verification.
Specify type of manometer.

3.15 Whether the final change

rooms have the same class of
air as specified for the aseptic
area.

3.16 Whether the pressure

differential in the change
rooms is in the descending
order, from ‘ white’ to’ black’.
Specify pressures of three
change rooms.
4. Environmental Monitoring

3.18 Whether temperature and

humidity (NMT 27 C and 55
C

% RH respectively) in the
aseptic areas are controlled.
4.1 Whether the records exist to
show that all the
environmental parameters
were verified at the time of
installation and checked
periodically thereafter?

39
4.2 Are the recommended periodic
monitoring frequencies
followed
a) Particulate counts -
6 Monthly

b) HEPA filters integrity testing –

Yearly

c) Air Change rates -

6 Monthly
d) Air pressure differentials -
Daily
e) Temperature and Humidity -
Daily
f) Microbiological monitoring by
settle plates and/ or swabs in:
Aseptic areas -- Daily,
Other areas -- Decreased
frequency
4.3 Does a written Environmental
Monitoring Program exist?
How long the settle plates are
exposed in Grade A and other
areas.
4.4 Are the microbiological results
recorded
4.5 Are these results assessed
with recommended limits
4.6 Do they take action in case
particulate and
microbiological monitoring
counts exceed the limits.
4.7 In case of major engineering
modifications being carried
out to the HVAC system of any
area, Whether all parameters
reassessed and approved
before starting production.

5. Garments

5.1 Whether Outdoor clothing is

allowed in the sterile areas
5.2 Do they use cotton garments
which are not allowed?

40
5.3 Are the garments made of
non- shedding and tight
weaving material?

5.4 Whether the garments are of

suitable design in single piece
with fastening at cuffs, neck
and at legs to ensure close fit
Trouser legs to be tucked
inside the cover Boots

5.5 Whether the garment includes

a hood or a separate hood
which can be tucked inside
the overall.
5.6 Whether Pockets, pleats and
belts are avoided
5.7 Whether Zips (if any used in
garments) are of plastic
material
5.8 Whether the personnel wear
only clean, sterilized and
protective garments at each
work session where aseptic
filtration and filling operations
are undertaken and at each
work shift for products
intended to be sterilized, post-
filling
5.9 Are masks and gloves are
changed at every work
session.
5.10 Are the gloves used made of
latex or other suitable plastic
material
5.11 Are powder free gloves used in
clean rooms
5.12 Are the gloves long enough to
cover the wrists completely
and allow the over-all cuff to
be tucked in
5.13 Are the foot-wear used made
of plastic or rubber material
5.14 Are the foot-wear daily
cleaned with a bactericide

41
5.15 Does the safety goggles /
numbered glasses worn in
side the aseptic areas have
side extensions
5.16 Are safety goggles sanitized by
a suitable method
5.17 Whether the garment
changing procedure
documented
5.18 Whether the operators trained
in garment changing
procedure.
5.19 Whether a full size mirror
been provided in the final
change room to ascertain that
the operator has appropriately
attired in the garments
6. Sanitation

6.1 Whether written procedures

available for sanitation of
sterile processing facilities

6.2 Whether the employees

carrying out the sanitation of
aseptic areas specially trained
for the purpose
6.3 Whether more than one
sanitizing agent is used in
rotation.
6.4 Whether the concentration of
the agent used has been
recommended by the
manufacturer
6.5 Whether distilled water is
used for the dilution of the
disinfectant, if so is it directly
collected from the distilled
water plant or from re-
circulation loop maintained
above 70 oC or sterilized by
autoclaving and filtered
through membrane filtration
6.6 Whether alcohol or isopropyl
alcohol is used as disinfectant
for hand sprays?

42
6.7 Whether disinfectant solutions
filtered through membrane
into suitable sterile containers
before use?
6.8 Whether the diluted
disinfectants bear ‘use before’
labels based on
microbiological establishment
of their germicidal properties
6.9 Whether records maintained
thereof
6.10 Whether fumigation carried
out in aseptic areas. If yes,
specify fumigating agent and
its conc. used.
6.11 Whether an SOP exist for the
purpose of fumigation.
6.12 Whether cleaning of sterile
processing facility done using
air suction devices non-linting
sponges or clothes.

6.13 Whether air particulate

quality monitored on a regular
basis
7. Equipments

7.1 Whether the unit- sterilizers

double ended with suitable
inter-locking between the
doors
7.1.1 Whether the initial
effectiveness of sterilization
process established by using
microbial spores indicators
7.1.2 Whether thermal Mapping of
heat sterilizers is carried out
on regular basis. Check
records.

7.1.3 Whether suitable vent filters

and recording thermographs
provided in Autoclaves.
7.1.4 Whether HEPA filters for
cooling air and recording
thermographs provided in
DHS

43
7.1.5 Whether provisions of CIP or
SIP available.

7.1.6 Whether firm has made

provisions for pure steam
generation and its use.
7.2 Whether filter integrity test
carried out before and after
the filtration process
7.3 Whether the filling machines
challenged initially and there
after periodically by
simulation trials including
sterile media fills.
7.4 Are SOPs with acceptance
criteria for media fills been
established, validated and
documented
7.5 Whether the material of
construction of the parts of
equipment which are in direct
contact with the product and
the manufacturing vessels of
stainless steel 316 and of
glass containers Boro-silicate
glass

7.6 Whether the tubing used

capable of washing and
autoclaving

7.7 Whether the installation

qualification been done of all
the equipments by the
engineers (with the support of
production and quality
assurance personnel)

7.8 Whether the critical processes

such as aseptic filling and
sterilizers suitably validated
before these were put to use

7.9 Whether SOPs available for

each equipment for its
calibration, operation and

44
 cleaning.
7.10 Whether the measuring
devices attached to equipment
calibrated at suitable
intervals.
7.11 Whether a written calibration
program is available

7.12 Whether calibration status

documented and displayed on
the of the equipment and the
gauges
8 Water & Steam Systems

8.1 Whether potable water used

for the preparation of purified
water meets the requirement
of not more than 500 cfu/ml
8.2 Whether potable water tested
(100 ml sample) for freedom
from pathogenic
microorganisms: Escherichia
coli, Salmonella,
Staphylococcus aurious and
Pseudomonas
8.3 Whether the Purified Water
prepared by de- mineralization
meet the microbiological
specification of not more than
100 cfu/ml
8.4 Whether Purified Water tested
for freedom from pathogenic
microorganisms. (Sample size
100 ml)
8.5 Whether Purified Water meet
IP specifications for chemical
testing

8.6 Whether purified water is

stored in stainless steel tanks.

8.7 Are the distribution lines

made of stainless steel 316
grades?

8.8 What is the water source for

preparation Water for

45
 Injection (WFI):
8.9 Whether WFI meet
microbiological specification of
not more than 10 cfu/100ml
8.10 Whether WFI meet IP
specifications for Water for
Injection
8.11 Whether WFI meet the
endotoxin level of not more
than 0.25 EU/ml
8.12 Whether WFI used for

8.12. - Bulk preparations of liquid

1 parenterals
- Final rinse of product
containers
8.12. - Final rinse of machine parts
2
8.12. - Preparation of disinfectant
3 solutions
for use in aseptic areas

8.13 Whether WFI used for liquid

injectables collected freshly
from the distillation plant or
from a storage / circulation
loop kept at above 70oC.

8.14 Whether the steam

condensate meets the
microbiological specification of
not more than 10 cfu/100ml
and IP specifications of WFI

8.15 Whether steam used in

production meet the endotoxin
level of not more than
0.25EU/ml
8.16 What is the schedule for the
monitoring of steam quality
exist

9. Manufacturing process

9.1 Whether the bulk raw

materials and bulk solutions
monitored for bio-burden

46
 periodically (solutions not to
contain more than 100
cfu/ml)
9.2 Whether the principle of
minimum possible time
between the preparation of the
solution and its sterilization or
filtration through
microorganism retaining
filters followed and also
specified in Master formula.
9.3 Whether the filter the gases
coming into contact with the
sterile product through two
0.22 micron hydrophobic
filters connected in series
9.4 Whether gas cylinders are
kept out side of the aseptic
areas
9.5 Whether the washed
containers sterilized
immediately before use

9.6 Whether the sterilized

containers not used within an
established time, rinsed with
distilled or filtered purified
water and re-sterilized
9.7 Is each lot of the finished
product filled in one
continuation operation

10. Terminally Sterilized product

10.1 Whether the preparation of

Primary packaging material
such as glass bottles,
ampoules and rubber stoppers
is carried out in at least Grade
D (grade C in case there is
unusual risk of contamination
to the product)

10.2 Whether these processes used

for component preparation

47
 have been validated.
10.3 Whether the filling area is of
Grade A environment with
Grade C background
10.4 Whether the solutions which
are sterilized by filtration is
prepared in Grade C
environment.
10.5 And if not to be filtered,
whether the preparation of
materials and products
carried out in Grade A
environment with Grade B
background

10.6 Whether for aseptic filling,

non- fiber releasing sterilizing
grade cartridge / membrane
filter of nominal pore size of
0.22 micron and 0.45 micron
porosity for terminally
sterilized products are used.
10.7 Whether a second filtration
with another 0.22 micron
sterilizing grade cartridge /
membrane filter, performed
immediately prior to filling.

10.8 Whether process

specifications indicate the
maximum time during which
a filtration system may be
used (precluding microbial
build-up to levels that may
affect the microbiological
quality of the product)
10.9 Whether integrity of the
sterilizing filter verified and
confirmed immediately after
use. If so, by which method:

Bubble Point, Diffusive Flow

or

Pressure Hold Test

Sterilization (Autoclaving)

48
10.10 Whether the sterilizing
processes have been validated
(Dry heat, Moist heat,
filtration, ETO, ionizations
whichever applicable.

10.11 Whether the validity of the

process verified at regular
intervals (at least annually)
10.12 Whether records are
maintained when significant
changes made to the
equipment and / or the
product.
10.13 Whether sterilizer double
ended
10.14 Whether the terminal
sterilizer’s capacity is
sufficient to sterilize one batch
completely at one time. If not
specify controls and measures
taken in lot sterilizations.
10.15 Whether the monitoring of
products bio-burden carried
out before terminal
sterilization.

10.16 Whether bio-burden controlled

to the specified limits in the
Master Formula.
10.17 Whether biological indicators
used in monitoring of
sterilization.
10.18 Whether the biological
indicators stored and used as
per manufacturers
instructions. Whether quality
of BI’s checked by positive
controls.
10.19 Whether a clear means of
differentiating ‘sterilized’ from
‘unsterilized‘ products in
place. Specify.
10.20 Whether the label on the
basket / tray or other carrier
of product / component
clearly states:

49
  Name of the material
 Its batch number
 Its sterilization status
Indicator (in case it has
passed through sterilization
process)
10.21 Whether sterilization records
including thermographs and
sterilization monitoring slips
attached with the Batch
Production Record
10.22 Sterilization (By Dry Heat)

10.23 Whether the sterilization cycle

recording device of suitable
size and precision provided in
DHS.
10.24 Whether the position of
temperature probes used for
controlling and / or recording
determined during validation
and (where applicable) been
checked against a second
independent temperature
probe located in the same
position
10.25 Whether the chart forms a
part of the batch record.
10.26 Whether sterilization cycle
validated only by biological
indicator and chemical
indicators or physical
validation is also carried out.
10.27 Whether the time allowed
reaching the required
temperature before
commencing the measurement
of sterilizing time, separately
determined for each type of
load.
10.28 Are adequate precautions
taken to protect the load
during cooling after it has
gone through the high
temperature phase of a heat
sterilization cycle

50
10.29 In case the cooling is affected
with any fluid or gas in
contact with the product , is it
sterilized.

10.30 Whether the equipment air

inlet and outlets been
provided with bacteria
retaining filters
10.31 In the process of sterilization
by dry heat, does the
equipment has:
 Air circulation facility
within the chambers

 Positive pressure to prevent

entry of non-sterile air

10.32 Whether the process of dry

heat sterilization is also
intended to remove the
pyrogens
If so, has the validation been
done with challenge tests
using endo-toxins

10.33 Sterilization (By Moist Heat)

10.34 Whether recording of both

temperature and pressure
carried out to monitor the
process
10.35 Whether the control
instrumentation independent
of the monitoring
instrumentation and recording
charts.
10.36 Whether the equipment has
automated control and
monitoring system, if so, have
these been validated to ensure
that critical process
requirements are met.

51
10.37 Whether the system and cycle
faults are recorded inbuilt and
also observed by the operator
and record maintained.
10.38 Whether the readings of the
thermograph during
sterilization cycling are
routinely checked by the
operator against the reading
shown by the dial
thermometer fitted with
autoclave.
10.39 Whether the sterilizer fitted
with a drain at the bottom of
the chamber

If so, does the record of

temperature at this position is
recorded through out the
sterilizing period
10.40 Are frequent leak tests
conducted on the chamber of
the autoclave on each day of
operation.
10.41 Whether all items to be
sterilized (other than sealed
containers) are wrapped for
sterilization.

10.42 Whether the wrapping

material allows removal of air
and penetration of steam
ensuring contact with the
sterilizing agent at the
required temperature for
required time
10.43 Whether the wrapping prevent
contamination after
sterilization

10.44 Whether the steam used for

sterilization is of suitable
quality and doesn’t contain
additives at a level which
could cause contamination of
the product or equipment

52
10.45 Whether the minimum time
for all unit operations and
processes are specified in the
manufacture of a batch
10.46 Whether the shortest validated
time being adhered from the
start of a batch to its ultimate
release for distribution
10.47 Whether the containers
closing methods been
validated

10.48 Whether the containers closed

by fusion e.g. glass or plastic
ampoules, subjected to 100%
leak testing

10.49 Whether the samples of other

containers checked for
integrity as per appropriate
procedures
10.50 Whether the containers sealed
under vacuum checked for
required vacuum conditions
10.51 Whether the filled containers
of parenterals inspected
individually for
extraneous contamination
/other defects
10.52 Whether the inspection
process done visually, if so,
are the illumination and
background conditions
controlled.
10.53 Whether the workers engaged
in inspection activity pass the
regular eye- sight test (with
spectacles if worn)
10.54 Whether the visual inspectors
allowed frequent rest from
inspection
10.55 If other method of inspection
of containers is used,
 What is the method-

 Has it been validated

53
  Are the equipment used for
the purpose checked at
suitable intervals
 Are the results/ recorded
maintained
11. Product Containers &
Closures
11.1 Whether the containers and
closures used comply to
pharmacopoeia or other
specific requirements
11.2 To assure suitability of the
containers/ closures and
other component parts of
drug packages, whether they
have:

Suitable sample sizes,

Specifications, Test methods,
Cleaning procedures,
Sterilizing procedures
11.3 Whether the container is
compatible with the product
and affecting its quality and
purity.
11.4 Whether second hand
containers and closures used

11.5 Whether the plastic granules

used checked for fulfillment
of Pharmacopoeia
requirements including
physico- chemical and
biological tests
11.6 Whether containers and the
closures rinsed with WFI
before sterilization

11.6. Whether a written procedure

1 exist for washing process. Do
they follow the written
schedule for cleaning of the
glass bottles

11.6. Whether the design of

2 closures and containers

54
 suitable to make cleaning
easy, and to make an air tight
seal when fitted to the
bottles
11.6. Whether the material quality
3 of the stoppers and closures
ensures that it does not affect
the quality of the product and
avoids the risk of toxicity
11.6. In case the bottles are not
4 dried after washing are these
rinsed with distilled water or
pyrogen free water as the case
may be as per written
procedure
12. Documentation

12.1 Do the manufacturing records

pertaining to manufacture of
sterile products indicate the
following details:
(1) Serial number of Batch
Manufacturing Record
(2) Name of the product

(3) Reference to Master Formula

Record
(4) Batch/ Lot number

(5) Batch/ Lot size

(6) Date of commencement and

completion of manufacture
(7) Date of manufacture and
assigned date of expiry
(8) Date of each step in
manufacturing
(9) Names of all ingredients with
grade given by the quality
control department
(!0) Quantity of all ingredients

(11) Control reference numbers for

all ingredients
(12) Time and duration of
blending, mixing etc. where
ever applicable

55
(!3) PH of solutions whenever
applicable
(14) Filter integrity testing records

(15) Temperature and humidity

records whenever applicable
(!6) Records of plate-counts
whenever applicable
(17) Results of pyrogen and/ or
bacterial endotoxin and
toxicity
(18) Records of weight or volume
of drug filled in containers
(19) Bulk sterility in case of
aseptically filled products
(20) Leak test records

(21) Inspection records

(22) Sterilization records including

leakage test records, load
details, date, duration,
temperature, pressure etc.
(23) Container washing records

(24) Total number of containers

filled
(25) Total number of containers
rejected at each stage
(26) Theoretical yield, permissible
yield, actual yield and
variation there of
(27) Clarification for variation in
yield
beyond permissible yield
(28) Reference number of relevant
analytical reports
(29) Details of re-processing, if
any
(30) Names of all operators
carrying out different activities
(31) Environmental monitoring
records
(32) Specimens of different
packaging material
(33) Records of destruction of
rejected containers and

56
 packaging material
(34) Signature of the competent
technical staff responsible for
manufacture and testing

13. Notes

13.1 Whether products released

only after complete filling and
testing.
13.2 Whether result of the tests
relating to sterility, pyrogens
and bacterial endotoxins are
maintained in the analytical
records
13.3 Whether Validation details
and simulation trial records
maintained separately
13.4 Whether records of
environmental monitoring like
temperature, humidity,
microbiological data etc., are
maintained.
13.5 Whether records of periodic
servicing of HEPA filters,
sterilizers and other periodic
maintenance of facilities and
equipment carried out, are
maintained.

Part-IB
Specific Requirements for manufacture of Oral Solid Dosage Forms (Tablets
and Capsules)

Requirements Yes No Additional Comments

/specific observations
noted with examples
1.1 Please specify HVAC and air
extraction systems provided to
avoid contamination from
extraneous particles / dust
and other products.
Whether HVAC and air
extraction system is capable of
preventing discharging

57
 contaminants into the
environment? In case of re-
circulation of air what is the
micron size of final filter.
1.1.1 Are there manometers to
monitor pressure differential
at all strategic points.
1.1.2 Is there schematic drawing of
AHU’s available.
1.1.3 Whether dedicated AHU’s for
different operations are in
place.
1.2 Please specify how specific
product requirements like
temperature, humidity and
light are controlled.
1.3 Pls specify the materials of
construction of equipments.
1.3.1 Whether metal detector is
used to detect metallic
contamination.
1.4 Whether dedicated areas for
sifting provided.
1.5 Pls give brief account on
pressure cascade (differential
pressure) being maintained in
the various areas of
production.
1.5.1 Whether pressure balancing is
automatic or manual.
1.5.2 Whether records of these
pressure differential reviewed
at regular interval. If yes pls
specify intervals of monitoring
and its review.
1.6 Is Air blowing or vacuum
system is used for clearing of
powders from the machine
parts etc.
1.6.1 In case of vacuum cleaning
how it is used to avoid
contamination and cross
contamination.
2
Sifting, Mixing and
Granulation: -

58
2.1 Whether mixing, sifting and
blending operations are
carried out in dedicated areas
& how generation of dust is
controlled.

2.1.1 Whether these operations are

closed.
2.1.2 Whether integrity of screens
checked before and after
operation.
2.1.3 Whether mixing and blending
equipment have timers for
control.
2.2 Whether personnel in
production carry out the
verification of the weight of the
raw materials used in the
manufacturing of each lot.
2.2.1 Whether critical operating
parameter likes time and
temperature for each mixing
and drying operation are
recorded in BPR and tally with
the master formula.
2.2.2 Whether static or fluid bed
dryers are used for drying.
2.2.3 Whether FBD and static dryers
have arrangements for
temperature monitoring and
recording.
2.4 Specify the system of using
filter bags used in FBD.

2.4.1 How filter bags are identified

for various products and
stored.
2.4.1 Whether air entering into the
dryers is filtered. If yes then
specify type of filters installed.
2.4.2 Whether air going out of FBD
is also filtered. If yes then
specify type of filters installed.
2.5 Whether granulation and
coating solutions are made,
stored and used in a manner

59
 which minimizes the risk of
contamination or microbial
growth.
2.5.1 Whether the washing facility in
the granulation suites takes
proper measures to prevent
contamination and cross
contamination.
3
Compression (Tablets) :-

3.1 Whether each compression

machine is installed in
separate cubicle.
What type of dust control
facilities are provided with the
Tablet compressing machine
in its cubicle.
3.2 How granules and compressed
tables stored and controlled to
prevent mix ups.

3.2.1 How these containers are

cleaned and maintained in a
proper condition.

3.3 How tablets are being

inspected and checked for
suitable pharmacopoeial
parameters like appearance,
weight variation,
disintegration, hardness,
friability, thickness and
records maintained thereof.

3.4 Whether instruments used in

IPQC lab are calibrated and
accurate to measure out of
specification units.

3.5 How tablets are being de-

dusted and monitored for the
presence of foreign materials.
3.7 Whether rejected or discarded
tablets are isolated in
identified container and their
quantity recorded in the BMR.

60
3.8 Which type of lubricating oil is
used in compression machine.

4
Coating (Tablets):-

4.1 Which type of tablet coaters

are provided for coating.
Whether air supplied to
coating pan is filtered. If yes
pls specify type of filter and
justification for its suitability.
Whether coating area is
provided with suitable exhaust
system and environmental
control (temperature,
Humidity) measures.
4.2 Whether coating solutions are
being made afresh and used.
5. Filling of Hard Gelatin
Capsule: -
5.1 How empty gelatin capsules
are stored and controlled in
the filling area.
5.1.1 Whether capsule filling is
carried out manually or by
machine.

5.1.2 Whether additional provisions

in the AHU’s has been made to
control humidity. If yes,
pleases specify the same.
6. Printing (tablets and capsules):
-
6.1 Whether the tablets / capsules
are overprinted. If yes which
type of ink is used. Please
specify quality of ink.
6.1.1 How printing operation is
controlled to avoid mix up of
products during printing.
6.1.2 Whether after printing, the
products are approved by
quality control before release
for packaging or sale.

61
7
Packaging (Strip & Blister)

7.1 Whether a system of line

clearance is in place and
recorded before a new
packaging operation is
commenced.
7.2 How contamination and cross
contamination are prevented
during packaging operation of
tablets / capsules.
7.3 How the strips/Blister coming
out of the machines is
inspected for defects such as
miss-print, cuts on the foil,
missing tablets and improper
sealing.
7.4 Whether IPQC tests are
performed on strips or
blisters? Whether records of
these tests maintained.

62
 PART-IC
(Specific Requirements for manufacture of Oral Liquid)

Requirements Yes No Additional Comments

/specific observations
noted with examples

Building and Equipments: -

1.1
How the facility for liquid
oral designed and
constructed to prevent cross
contamination and mix-ups.

1.1.1
Whether the manufacturing
area have entrance through
double air lock facility.
1.1.2 Whether in the
manufacturing area walls,
floors and ceiling are
impervious, non-shedding,
non-cracking, coved at all
junctions.
Whether the doors and
windows and light fixtures
are flushed, made up of non
fiber shedding material.
Whether fly catcher and/or
1.2 air carton has been provided
at strategic suitable points.
1.3 Whether the drains are
provided with traps to
prevent back flow.
How drains are maintained.

1.4 Whether the production area

is cleaned and sanitized at
the end of every production
process. If yes, whether
records maintained.
(How the area is sanitized.
How sanitization procedures
controlled).

63
1.5, 1.6 What is the material of
& 1.8 construction of tanks,
containers, Pipe work and
pumps?
Whether the tanks have
clean in place
facility. If not how tanks are
cleaned to prevent
accumulation of residual
microbial growth and cross-
contamination.
How tanks, pipe works and
other containers sanitized.
Whether the pipelines and
services have any dust
lodging surface.
Whether microbial
monitoring of the area is
carried out.
Whether use of glass
containers is restricted.

Whether furniture's are of

stainless steel and are
capable of cleaned effectively.
1.7 Whether cleaning of bottles,
caps, droppers etc are
carried out by suitable
machine/devices equipped
with high pressure air, water
and steam jets.
2
Purified Water: -
2.1 Whether the Microbial
quality of purified water is
monitored routinely.
(What is the in house limit of
CFU / ml of purified water).
Whether water is tested for
freedom from Pathogen on
daily basis. If not what is
the schedule.
2.2 Whether the unit has written
procedure for operation and
maintenance of purified
water system. (Specify the
method).

64
3
Manufacturing: -

3.1 What types of clothing’s are

3.2 worn by personnel in
manufacturing area?
Whether materials like
gunny bags, or wooden
pallets are allowed in
manufacturing areas.
3.3 Whether suspensions and
emulsions are manufactured.
If yes how homogeneity of the
same is ensured throughout
the process.
3.4 Whether separate syrup
preparation area has been
provided,`

Specify the room

temperature requirement in
the manufacturing area.
3.5 Whether the maximum
period of storage of product
in a bulk stage is validated
and mentioned in MFR.

65
 PART-ID
(Specific Requirements for manufacture of topical products (Ointment,
Creams, Lotion & Dusting Powders)

Requirements Yes No Additional Comments

/specific observations
noted with examples
1 Whether the entrance to
manufacturing area is
through an air lock.
Whether air lock is supplied
with filtered air.
Whether insectocutor has
been installed out side air
lock.
2&3 Whether HVAC system
installed in manufacturing
areas. If not how air quality
is maintained.
Which filter is used for air
filtration to the mfg. Area.
How temperature in the mfg.
Area controlled.
How fumes, vapors if
generated during the
process are controlled.
4&5 What is the material of
construction of tanks,
containers, Pipe work and
pumps?
Whether the tanks have
clean in place facility. If not
how tanks are cleaned.
What type of transfer pumps
is used. And precaution
taken to protect the product
from the contamination.
How tanks, pipe works and
other containers sanitized.
6. Whether water used in the
compounding is purified
water IP.
7 Whether the powders
whenever used are suitably
sieved.
How contamination with
metals prevented.

66
8. How heating of base like
petroleum jelly is done in
the vessels.
Whether melting facility is
separate / dedicated to the
process.
9 Whether a separate packing
section is provided for
primary packaging of
products.
Whether product is filled in
tubes or jars.
How jars are cleaned before
filling.

67
 Checklist for assessment of validation system

Yes No Specific
Requirements Observations/comments
1 Is there a master plan (Master
validation plan) covering:
1.1 Resources and those responsible
for its implementation.

1.2 Identification of the systems and

processes to be validated

1.3 Documentation and standard

operating procedures (SOPs), Work
Instructions and Standards
(applicable national and
international standards)
1.4 Validation list: facilities,processes
(e.g. aseptic filling), products
1.5 Key approval criteria
1.6 Protocol format
1.7 Each validation activity, including
re-validation and reasonable
unforeseen events (power failures,
system crash and recovery,
filter integrity failurer.
Please attach validation calendar.
2. Pls specify whether the critical
processes validated Prospectively,
retrospectively or concurrently.
3. Whether validation of following
performed and documented:
Analytical methods, Production
and assay equipment, Sterile
production processes, Non-sterile
production processes, Cleaning
procedures, Critical support
systems (purified water, water for
injections, air,
vapor, etc.), Facilities
4. Please list reasons considered
important for validation or re-
validation.

68
5. In case electronic data processing
systems are used, are these
validated?
Please specify whether periodical
challenge tests performed on the
system to verify reliability.
6. Are the validation studies
performed according to pre-
defined protocols?
Is a written report summarized,
results and conclusions prepared
and maintained?
Is the validity of the critical
processes and procedures
established based on a validation
study?
7. Are criteria established to assess
the changes originating a
revalidation?
Are trend analyses performed to
assess the need to re-validate in
order to assure the processes and
procedures continue to obtain the
desired results?
8 WATER SYSTEM
PURIFIED WATER
WATER FOR INJECTIONS
8.1 Please specify whether waster
system qualification (IQ, OQ and
PQ) has been carried out as per
protocol and repots have been
prepared and maintained.
8.2 Whether IQ protocol include at
least facility review, equipment
specification vs. design, welding
roughness testing on pipelines,
absence of dead points / section
in the pipelines, pipe and tank
passivation, drawings, SOP for
operations, cleaning, sanitation,
maintenance and calibration of
gadgets. Whether its report
includes Conclusion / Summary,
description of the performed
assay, Data tables, Results,
Conclusions, Protocol reference,
Revision and approval signatures.

69
8.3 Whether OQ protocol include at
least System production capacity
(L/min), Flow type and water rate,
Valve operation, Alarm system
operation and Controls operation?
8.4 Whether its report includes
Conclusion / Summary,
description of the performed
assay, Data tables, Results,
Conclusions, Protocol reference,
Revision and approval signatures.
8.5 Please specify the water whether NO
Phase 1, Phase 2 and Phase 3
studies carried out in at PQ
stages?
8.5.1 Phase 1 : Whether the operations NO
parameters, cleaning and
sanitation procedures &
frequencies defined.
Whether daily sampling records
for every pretreatment point and
usage point for a period of 2 to 4
weeks maintained and SOP’s
prepared.
8.5.2 PHASE 2 : Whether daily sampling NO
records for every pretreatment
point and usage point for a period
of 4 to 5 weeks after Phase 1
maintained and reviewed.
8.5.3 PHASE 3 : Whether weekly NO
sampling records available of every
usage point for a one-year period.
In the case of water for injections
systems, are the daily sampling
records of at least one usage point
available, with all the usage points
sampled weekly?
Whether results of these records
summarized to show suitability.
Are there personnel training
records?
9. EQUIPMENT

70
9.1 Are the equipment installation NO
Qualification (IQ) protocols
contains followings: Introduction,
Installation description,
Responsibilities, Performed
tests/assays, Qualification
acceptance criteria and Data
recording and reporting?
Whether report contains NO
Summary, Description of
performed tests/assays, Obtained
data tables, Results, Conclusions,
Installation diagrams, Revision
and approval signatures.
9.2 Whether the equipment operation NO
qualification (OQ) protocols
contains following: Introduction,
Equipment description,
Description of the equipment
operation steps (SOP’s),
Responsibilities, Qualification
acceptance criteria, Data recording
and reporting. Whether report
contains Summary, Description of
performed tests/assays, Obtained
data tables, Results, Conclusions,
Revision and approval signatures.
9.3 Whether equipment performance NO
qualification (PQ) protocols
contains followings: Introduction,
Responsibilities, Performed
assays, Qualification acceptance
criteria, Data recording and
reporting.
Whether report contains
Summary, Description of
performed tests/assays, Obtained
data tables, Results, Conclusions,
Revision and approval signatures.
10. Analytical Method Validation NO

71
10.1 Please specify whether following NO
Characteristics are considered
during validation of analytical
methods:
— specificity
— linearity
— range
— accuracy
— precision
— detection limit
— quantitation limit
— Robustness.
10.2 Whether Paharmocopial methods NO
are also validated. If yes, how.
10.3 Whether system suitable testing is YES
included in testing protocols e.g.
HPLC, GC etc.
11 CLEANING
11.1 Is a validation performed to YES
confirm cleaning effectiveness?
Does the protocol define the YES
selection criteria for products or
groups of products subject to
cleaning validation?
Is data produced supporting the YES
conclusion that residues were
removed to an acceptable level?
11.2 Please specify whether the
validation is implemented to verify
cleaning of:
Surfaces in contact with the
product, After a change in
product, Between shift batches.
Please specify whether the
Validation Strategy include
contamination risks, equipment
storage time, the need to store
equipment dry and sterilize and
free of pyrogens if necessary?

72
11.3 Whether the cleaning Validation
Protocol include:
a. Interval between the end of
production and the
beginning of the cleaning
SOP’s.
b. Cleaning SOP’s to be used.
c. Any monitoring equipment
to be used.
d. Number of consecutive
cleaning cycles performed?
e. Clearly defined sampling
points.
11.4 Whether Quality Control
responsible of the sampling for
cleaning verification?
11.5 Whether personnel engaged in
cleaning, sampling etc. trained.
11.6 Please specify whether acceptance
limits been set for cleaning
verification and are based on
following criteria:
a. Visually clean.
b. 10 ppm in another product
c. 0.1% of the therapeutic
dose?
11.7 Please specify whether detergent
residues investigated and
degradation products verified
during validation.
11.7. Whether validation records include
1 Recovery study data, Analytical
methods including Detection
Limits and
Quantification Limits, Acceptance
Criteria, Signatures of the Quality
Assurance Manager, employee in
charge of cleaning and the
verification from Production and
Quality Control.

12 HVAC

73
12.1 Please specify whether following
parameters have been qualified:
— temperature
— relative humidity
— supply air quantities for all
diffusers
— return air or exhaust air
quantities
— room air change rates
— room pressures (pressure
differentials)
— room airflow patterns
— unidirectional flow velocities
— containment system velocities
—filter penetration tests (HEPA)
— room particle counts
— room clean-up rates
— microbiological air and surface
counts where appropriate
— operation of de-dusting
— warning/alarm systems where
applicable.
12.2 Whether strategic tests like NO
Particle count, air pressure
differential, air flow volume, air
flow velocity etc. included in HVAC
qualification.
13 Media fill test NO
13.1 Whether medial fill tests carried NO
out twice in a year during normal
working conditions.
NO
Pls give date of last such test.
13.2 How many units are filled and NO
tested.
What is the criterion for NO
qualification of this test?
13.3 In case of failure of media fill test, NO
what precautions or actions are
taken.

74
 Check List for Self inspection/Assessment of Good Laboratory Practices
based on Schedule- L1 of Drugs and Cosmetic Rules

Clause Requirements Yes No Specific

No. Observations
/Comments
supported with
examples
1. General Requirements:

a. The laboratory or the organization YES

of which it is a part must be an
entity that is legally authorized to
function and can be held legally
responsible.

b. It is the responsibility of the YES

management to ensure that the
laboratory carry out its testing,
calibration, validation, and all
other technical activities in such a
way as to meet Good Laboratory
Practices (GLP) requirements.
c. Laboratory management shall have YES
a qualified individual to be known
as quality manager or technical
manager for carrying out all
technical activities and for the
implementation of documented
quality system and shall report to
the top management directly.
d. The quality manager shall prepare YES
a schedule for technical audit of
the laboratory for GLP compliance
by an expert or experts appointed
by the top-management other than
the in-charge of the laboratory and
shall ensures the maintenance of
documented quality system as per
quality, manual
2. Premises:
a 1 the laboratories shall be designed, YES
constructed and maintained so as
to prevent entry of insects and
rodents besides cross
contamination;

75
 2 interior surface (walls, floor, and YES
ceilings) shall be smooth and free
from cracks, and permit easy
cleaning and disinfection;
3 adequate provision is made not YES
only for space and equipment for
carrying out necessary test but
also for utilities like water, power
and gas;
4 air ventilation system shall ensure YES
dust free environment.
b. The laboratories shall be provided YES
with adequate lighting and
ventilation and if necessary, air-
conditioning to maintain
satisfactory temperature and
relative humidity that will not
adversely affect the testing and
storage of drugs or the accuracy of
the functioning of the laboratory
equipments or instruments.
c. The drainage system facilities shall YES
be such as to facilitate proper
maintenance and prevent water
logging in the laboratory.
d. Tabletops shall be constructed YES
with acid, alkali and solvent
resistant material and shall be
smooth and free from crevices as
far as possible
e. All bio-medical laboratory waste NO
shall be destroyed as per the
provisions of the Bio- Medical
waste (Management and Handling)
Rules, 1996.
f. Adequate space with proper YES
storage conditions in the
laboratory shall be provided for
keeping reference and working
standards and be maintained by
the quality control department.
Standard Operating Procedure
(SOP) for the maintenance of
reference standards and
evaluation of Working and
Secondary standards shall be
prepared by the laboratory.

76
g. The air circulation is maintained NO
in the area where sterility test is
carried out as per" Schedule 'M'.
h. Bio-burden shall be routinely NO
maintained in the controlled and
uncontrolled area, (e.g.. Air locks)
(i) Animal House shall have the NO
approval of the Committee for the
Purpose of Control and
Supervision on Experiments on
Animals (CPCSEA).
(ii) Designed in such a way that there NO
is an arrangement to quarantine
the new animals procured or
purchased and have a provision for
clean corridor and dirty corridor.
(iii) In case of a diseased animal proper NO
diagnosis shall be done and proper
record of treatment shall be
maintained.
(iv) Different types of animals shall be NO
housed separately with proper
identification
(v) A Standard Operating Procedure NO
shall be prepared for breeding and
care of animals, maintenance,
cleaning or sanitation with suitable
schedule for cleaning of animal
cages, racks, floor and other
equipments.
(vi) The animal house shall have NO
proper air-conditioning
(temperature and humidity) with
proper lighting and be monitored
regularly and documented
periodically.
3 Personal:
a. Staff in the laboratory shall YES
possess necessary qualification,
proper training and shall have
adequate, experience for the
assigned duties.
b. A training record of all the YES
personnel shall be maintained.

c. Head of the laboratory must be of YES

high professional standing with

77
 experience in drug analysis and
laboratory management who is
responsible for.
(i) ensuring the control and YES
maintenance of documents
including the quality system as per
the requirements of regulatory
authorities which involves all raw
data, SOPs, documentation
exhibits, protocols, training charts,
etc;
(ii) planning and organizing the audit YES
of the quality system and initiation
as well as follow up action of the
corrective actions, if any;
(iii) investigation of technical NO
complaints;
(iv) Taking final responsibilities for NO
recommending any regulatory
action in the event of
noncompliance of tested samples.
4. Equipments :
a. The laboratory shall be furnished YES
with all types of equipments as
may be necessary for carrying out
the different activities within the
laboratory.
b. The analytical instruments shall NO
be housed in dust-free
environment and whenever
required,' conditions of
temperature and humidity shall be
maintained and periodic checks on
temperature and humidity be
made and recorded.
c. The instruments, instrument YES
bench and surrounding areas shall
be kept clean and tidy at all times.
d. Instruments requiring calibration YES
shall be calibrated at regular
intervals and records of such
calibration or maintenance be
maintained and there shall be
written instructions in the form of
Standard Operating Procedures for
the operation, maintenance and
calibration of instruments.

78
e. Equipment records shall be
maintained and such records shall
contain the following:-
(i) name of equipment or machine or YES
apparatus
(ii) manufacturer's name, model YES
number and type of identification;
(iii) serial number; YES
(iv) date on which equipment was NO
received in laboratory;
(v) current location; -- --
(vi) condition when received (e.g. new,
used, re-conditioned);
(vii) copy of the manufacturer's
operating instructions;

(viii) frequency of calibration

(ix) frequency of maintenance
(x) log Book (day to day entry YES
including status of the equipment)
(xi) staff responsible for monitoring the YES
calibration and maintenance
status of the equipment;
(xii) calibrating records; YES
(xiii) list of authorized users or YES
operators, if any;

(xiv) history of any damage, YES

malfunction, modification or up
gradation, repair and calibration;
(xv) List of spares and accessories, if YES
any.
A progress register for non-
f. functional equipments and action
for procurement of spares and
accessories, monitoring thereof,
shall be maintained.
g. A Standard Operating Procedure YES
for preventive maintenance of
machine or equipment or
apparatus shall be prepared by the
laboratory.
h. Other equipments such as YES
burettes, pipettes, volumetric
flasks, weight boxes,
thermometers, etc., shall be

79
 thoroughly checked for accuracy of
calibration before acceptance for
use.
i. Maintenance procedure in the YES
form of Standard Operating
Procedures must be prepared and
regular servicing must be
performed by the maintenance
engineer or specialist
j. Equipments, instruments giving YES
anomalous results or defective
must be labeled as 'out-of order'
till they are repaired and after
instrument is repaired it should be
calibrated before use
The maintenance of equipments YES
k. for services like electricity, gas,
water, steam, and compressed gas
shall be handled by competent
person.
l. Autoclaves must meet the
requirements described for
operations, safety and validation
procedures, and the validation
carried out by the laboratory shall
be recorded.
m. Fume Cupboards.-
Work involving the evolution of
harmful and obnoxious vapors
shall be carried out in a fume
cupboard. The exhaust system of
the fume cupboard shall be
checked frequently to ensure that
it is in order. There should be a
water drainage system inside the
fume cupboard and shall be
checked frequently to ensure that
there is no
water logging and it is in order.
5. Chemicals and Reagents:
a. The storage and handling of YES
chemicals and reagents shall be
done in a manner considering the
physicochemical properties of
these substances and the hazards
involved in their use.
b. All reagents and solutions in the

80
 laboratory shall be properly
identified with a label.
c. A standardization register shall be YES
maintained by the laboratory along
'with its raw data and Standard
Operating Procedure for
preparation and standardisation
on stock solutions, standard
solutions, volumetric solutions
must be prepared for the guidance
of staff.
d. Containers of stock solutions and YES
of standard solutions shall bear
the following details:-
(i) name of analytical chemist who YES
prepared the solution;
(ii) date of preparation; YES
(iii) Each volumetric solution shall YES
have "use before date" depending
upon the stability of the solution;
and
(iv) Standardization records. YES
e. The transfer of hazardous
chemicals and regents from one
container to another container
shall be carried out with suitable
equipment by taking the care of
safety and no make-shift or
hazardous methods must be
resorted to.

YES
6. Good housekeeping and safety:
a. General and specific written down NO
instructions for safety shall be
circulated to each staff member
and the instructions be revised
periodically as appropriate (e.g.,
poster displays, audio-visual
material and by
seminars/conferences)
b. Standard Operating Procedure for YES
safety, house-keeping and loss
prevention shall be prepared in
accordance with the various rules,
and regulations of the Government
of India and include the following

81
 requirements, namely:-

(i) safety data sheets must be made

available to staff before testing is
carried .out;
(ii) Drinking, eating and smoking NO
shall not be permitted in the
laboratories; food for human
consumption shall not be kept in
working or storage areas; food
meant for test animals shall be
handled by the workers under the
guidance of a veterinary doctor or
qualified person. In the animal
house, the facilities for collection
and disposal of animal waste or
safe sanitary storage of waste
before removal from testing be
provided;
(iii) staff must wear laboratory coats or YES
other protective clothing including
gloves and face masks and eye
protection wherever required;
(iv) the laboratories shall have YES
adequate first aid kit and-fire
fighting equipments located at the
right places and the staff must be
familiar and trained with the use
of firefighting equipment including
fire extinguishers, fire blankets
and gas masks,
(v) operators carrying out sterility NO
tests shall wear sterilised
garments including headgear, face
masks and shoes;
(vi) the staff must be educated in the Yes
first aid techniques, emergency
care and use of antidotes; and
(vii) safety rules in handling cylinders Yes
of compressed gases must be
observed and staff must be
familiar with relevant colour
identification codes;
c. Protective Precautions to be taken YES
in Laboratories
(i) water showers shall be installed at NO

82
 appropriate places in the
laboratory

(ii) rubber suction bulbs must be Yes

used on manual pipettes and
siphons
(iii) warnings, precautions, and written NO
instructions must be given for
work with violent, uncontrollable
or dangerous reactions (e.g. mixing
water and acids, biological such as
infectious agents, etc.);
(iv) appropriate facilities for the YES
collection, storage, and disposal of
wastes shall be made available.
(v) staff must be aware of methods for YES
safe disposal of corrosive or
dangerous products by
neutralisation or deactivation and
of the need for complete disposal
of mercury and its salts.
(vi) staff must also be aware about the NO
safety precautions to be adopted
while handling potassium cyanide
and cyanogen bromide.
(vii) a Standard Operating Procedure NO
for handling, collection, disposal of
chemical and biological wastes be
prepared.
7. Maintenance, calibration, and YES
validation of equipments :
a. All equipments, instruments and YES
other devices used in the
laboratory shall use appropriate
methods and procedures for all a
tests or calibrations and they shall
be regularly calibrated and
validated. The frequency of
calibration may differ from
instrument to instrument.
b. The original equipment YES
manufacturers recommendations
along with the experience of the
laboratory staff and the use of
equipment per day may also be
considered while fixing the
frequency of calibration.

83
c. For most of the equipments and YES
instruments, Standard Operating
Procedures for calibration and
calibration schedule be prepared
by the laboratory and a logbook
shall also be prepared by each
laboratory for proper
documentation of calibration
results.
8. Reference Materials:
a. Reference materials are necessary NO
for the testing and, or calibration,
validation or verification of a
sample or of equipment,
instruments or other devices and
all such materials shall be
traceable to agency authorized by
Government of India or any other
International body.
b. The laboratory shall prepare
working standard by comparing
with the reference standards and
shall be routinely checked for their
purity by selecting parameters
such as identity, loss on drying or
on water, impurity and assay, etc.
c. Whenever, any new reference
material is received by the
laboratory, a code number shall be
assigned and this code number
shall be quoted on the laboratory
note book and analytical work
sheet. The working standard shall
also be provided with identification
code.
d. A register pertaining to reference
and working materials must be
maintained by the laboratory. The
following details may be mentioned
in the register:
(i) source of supply
(ii) code number of the reference
material
(iii) date of receipt
(iv) batch number or identification
number of the supplying agency
(v) details like assay value, water

84
 content or any other information
provided
(vi) storage condition of the material;
and
(vii) Date of expiry. if any and date of
manufacturing if possible
e. All working standards shall be
checked at appropriate intervals or
before use to ensure that it has
not deteriorated or decomposed
during storage. These observations
be recorded in a register. All the
reference and working standards
shall be stored at appropriate
storage condition; those requiring
storage between 2-8°C shall be
stored in a refrigerator. Wherever
recommended the material may
not be allowed to be frozen
9. Microbiological Cultures:
a. Standard Operating Procedure for
maintenance of microbial culture
and sub-culture must be prepared
by the laboratories
b. If the cultures have become non-
viable or mutant, proper procedure
shall be followed to destroy these
cultures by autoclaving under an
authorised personnel for biological
testing. Preferably not more than
five passages may be prepared.
c. All activities be carried out in a
aseptic area by authorized person
d. The laboratories shall perform
standard biochemical tests on the
sub-culture as given in literature
to ensure their viability,
10. Quality system :
The quality system shall be
designed to ensure the following
objectives:-
a. The measurements and
calibrations shall fully conform to
the compendia requirements and
the methods demonstrably based
on validation protocols are
followed.

85
b. It shall be effective in providing
necessary assurance that the
activities or processes or
techniques or practices comply
with planned arrangements.
c. It helps in early detection and
correction of non conformities.
d. Remedial action on the
observations by internal and
external audits are taken
appropriately and
e. It shall have a documented quality
policy for the organization
11. Internal quality system audits:
a. Internal audits are done to assure
the integrity of the analysis and
such audits shall be conducted
periodically with a predetermined
schedule and procedure with
appropriate checklist, to verify that
the operations continue to comply
with the requirements of quality
system and requirements of
regulatory authorities. Internal
quality audits shall be carried out
by trained and qualified personnel
who are independent of
the activity to be audited.

b. The periodicity of quality audit

shall be fixed by the Head of the
laboratory so that each activity is
audited at least once in a year.

d. Whenever any non-compliance or

any diversion is noticed by the
team in implementing quality
policy or quality system, protocols,
the same will be attended by the
Quality Manager. The problem will
be analysed and necessary actions
will be taken with proper
documentation.
e. The Quality Manager shall
maintain all the records of the
analysis being conducted which

86
 includes test system, the type of
analysis, date on which analysis is
done, etc and quality Manager
shall also maintain copies of all
protocols pertaining to different
activities being checked by the
audit team.
12. Management review:
Quality system reviews shall be
conducted by the top management
atleast once in every twelve
months and the agenda of review
shall generally cover the following:-
(i) report or input of internal audits;
(ii) matter arising from previous
reviews
(iii) report of external audits, if any; No
(iv) surveillance report, if any; No
(v) result of proficiency testing No
(vi) complaints or feedback received No
from users of laboratory services;
(vii) details of in-house quality control yes
checks;
(viii) need of amendment of the quality yes
system and documentation
(ix) induction training of new staff; yes
and
(x) any other requirements of the yes
laboratory
13. Standard Operating Procedures:
a. Standard Operating Procedures yes
are written procedures for different
activities being conducted in a
laboratory and shall include the
following characteristics:
(i) they shall be written in a no
chronological order listing different
steps leading to an analysis of
drugs or calibration of an
instrument:
(ii) testing laboratories shall have yes
Standard Operative Procedure
manuals and have its periodic
review;
(iii) It shall be user friendly documents
and shall include designation of

87
 the person responsible for
intended activity.
b. Standard Operating Procedures in yes
addition to those recommended
under various activities shall also
be prepared to the minimum in
respect of the following:
(i) sample handling and yes
accountability;
(ii) receipt identification, storage, yes
mixing and method sampling of
the test and control articles;
(iii) record keeping, reporting, storage yes
and retrieval of data;
(iv) coding of different studies, No
handling of data including use of
computerized data system;
(v) operation of technical audit Office
personnel in performing and
reporting audits, inspections and
final report reviews;
(vi) routine inspection of cleaning, yes
maintenance, testing, calibration
and standardization of
instruments;
(vii) action to be taken in respect of yes
equipment failure
(viii) analytical data methods yes
(ix) the raw data yes
(x) data handling and storage retrieval yes
(xi) health and safety protection yes
(xii) animal room preparations No
(xiii) animal care NO
(xiv) storage and maintenance of
microbial cultures

(xv) maintenance of sterility room (Le.

constant maintenance and
monitoring of Aseptic condition of
sterility room);
(xvi) use and storage of reference
standards
(xvii) procurement of stores and
equipment
(xviii) monitoring of testing of samples;
(xix) method of retention of unexpended

88
 samples their maintenance and
disposal;
(xx) document control
(xxi) redressal of technical complaints
(xxii) housing-keeping
(xxiii) corrective and preventing action;
(xxiv) working procedure (test methods)
(xxv) calibration Manual; and
14. Protocols and specifications
archive:
a. Every laboratory shall have a YES
specification archive and current
versions of all necessary
specifications shall be kept as per
the requirements of the Act and
the rules made there under and
the National Pharmacopoeia
(Indian Pharmacopoeia).
b. All updates and corrections must YES
be noted in the master volumes of
Pharmacopoeias to prevent the use
of obsolete sections; supplement
and addendum shall also be made
available in the laboratory.
c. The specification archive shall
contain the following
(i) list of all the pharmacopoeias I.P
(ii) a file on patent and proprietary
medicines (non-pharmacopoeial)
test methods to specifications
prepared and validated the
manufacturer or the laboratory
itself. The test methods shall be
submitted to the concerned Drug
Control Authority. The validated
test methods developed by the
manufacturer or the laboratory
shall stand to the requirements of
compendia parameters in regard to
its precision, accuracy,
reproducibility, specificity,
linearity, and ruggedness etc.

15. Raw data:

a. Raw data refers to the laboratory YES
work sheet, note books or analysis

89
 sheet, records, memorandum,
notes or extract copies thereof that
may be the results of general
observations and other activities
and such raw data shall include
hand written notes, photographs,
software, drawings, computer
printouts, spectral charts, dictated
observations or recorded data from
automated equipments. The raw
data also includes record on
receipt of animals, result of
environmental monitoring,
calibration, records of equipments,
integrator output from analytical
equipment, including work-sheet
used to read a note, information
from Light Emitting Diode (LED)
display of any equipment.
b. A single line shall strike through
the data being changed; the
correct information shall be
recorded along with the old data
and the reason of change. The
analyst making the change shall
be identified by his signature with
date. In case of automated data
collection system, the person
responsible shall be identified at
the time of data output. The
original entry must be saved and
the system have audit trial for all
the data

c. Data integrity and security shall

be maintained and the data shall
not be accessible to any
unauthorized person.

The information provided in the forgoing self assessment checklist is

correct and true. I understand that any information given above, if found
false will make the firm liable for administrative /legal action under the
provision of the Drugs and Cosmetics Act 1940 and rules there under.

Sign & Date

Authorized Signatory Suchita Bari

90
Name and Address of the firm
Devendra Kirti Pharma Chem Pvt. Ltd.
N-45, M.I.D.C. Industrial area, Tarapur,
Boisar.

91