Pharmacy Quality Assurance

Pharmacy Quality Assurance
Students: Mariana Molina

Teacher: Andrea Loreto
Section: 20
 Definition of Quality
1
Quality refers to the ability of an object to satisfy implicit or explicit needs according to
a parameter, a fulfillment of quality requirements.
 Definition of quality control
Quality control as a process must take into consideration the planning, control and
improvement stages. Quality, in this sense, not only refers to the durability of a product or
satisfaction with a service, but also implies meeting standards of financial profitability,
commercial growth and technical safety defined by the company's management.
 Definition of ISO Standards
ISO is the International Organization for Standardization, which regulates a series of

standards for manufacturing, commerce and communication, in all industrial branches.
Organization as well as the standards established by it to standardize production and
control processes in international companies and organizations .
ISO standards address different aspects of production and commerce, but some of them
include those that regulate the measurement of paper, the name of languages,
bibliographic citations, country and currency codes, representation of time and the date,
quality management systems, C and BASIC programming languages, software life cycle,
requirements regarding competence in testing and calibration laboratories, .odf
documents, .pdf documents, failure guarantees on CD-ROMs , information security
management systems, and many others.
 Good Manufacturing Practices
To ensure the quality of a medicine, there must not only be a reliable system of
procedures for authorizing registration and marketing, but there must also be independent
inspection that certifies that all manufacturing operations are in compliance with standards
or as commonly stated. know: “Good Manufacturing Practices”.
In Chile, although the ISP put into force the basic standards recommended by the World
Health Organization (WHO) in 1992 - ratified by the World Health Assembly on May 10,
1994, to be complied with by pharmaceutical laboratories As of May 1, 2002, the authority
has not been peremptory in its compliance, and has continually extended the deadlines for
2
national laboratories, which is why basic quality assurance has been delayed for over a
decade.
As of June 2013, one third of the laboratories in Chile audited by ISP/ANAMED do not
comply with BMP as recommended by the WHO.
 Quality assurance
Quality assurance in its broadest form can be defined as the set of actions that companies
take with the purpose of being able to deliver goods and services to consumers with the
expected level of quality.
Applying a quality assurance system generates confidence and security in companies that
their products will meet the appropriate conditions of expected quality. Consequently, for
this purpose, quality standards are applied under a system that allows organization,
direction and control within the entire process that is developed.
It can also be said that quality assurance is an audit that verifies that quality standards are
met, that is, it controls that all the minimum requirements expected in the product are met.
Then, for companies to comply with quality assurance, it is necessary that they follow a
line of actions that are previously planned, systematized and finally implemented as a set
of standards that the company has to follow.
 Bioequivalence
Each pharmaceutical formulation is unique in its biopharmaceutical behavior, so the

requirement for bioavailability/bioequivalence studies is a determining factor in the clinical
response. For this reason, it is of utmost importance that bioequivalent medications
demonstrate the same therapeutic efficacy as the reference product.
 Pharmacovigilance
3
According to Decree 3/11, Pharmacovigilance is the "set of activities related to the
detection, evaluation, understanding and prevention of adverse effects associated with the
use of medications."
This element includes the adequate recording and analysis of voluntarily reported adverse
reactions with precise identification of the manufacturer of the reported product, including
name and serial or manufacturing batch number.
In Chile, this system is not satisfactorily in place, as it is limited to the processing of

voluntarily reported adverse reactions, which is why CIF and its partners are committed to
promoting a program that incorporates the concept of “adverse effects.”
Currently, the standard that regulates pharmacovigilance in our country is Technical

Standard No. 140 on the National Pharmacogilance System for Pharmaceutical
Products for Human Use.
 Good Storage and Distribution Practices
Good Storage and Distribution Practices (BPAD) constitute a set of mandatory minimum
storage, distribution and transportation standards that import, distribution, transportation,
dispensing and sale warehouses of pharmaceutical and related products must comply
with, with respect to the facilities, equipment and operating procedures, intended to
guarantee the maintenance of the characteristics and properties of the products and their
traceability throughout the supply chain. This Manual has been prepared in a manner
consistent with the principles and guidelines issued by the Organization
Bioavailability is the degree and speed with which an active form (the drug or one of its
metabolites) enters the circulation, and thus reaches its site of action.
The bioavailability of a drug depends largely on the properties of the dosage form, which
in turn depend in part on its design and manufacturing. Differences in bioavailability
between different formulations of the same drug may have clinical importance;
Therefore, it is essential to know whether different formulations of a drug are equivalent
or not.
 Polluting Agents
4
Chemical contaminants, also called chemical agents, are substances that, due to the way
they are presented, can be absorbed by the body and produce, in a short time, or over
years, harmful effects on the individual's health. They can be counted in thousands, some
being of natural origin and others of artificial origin (created by man). They can cause harm
if the amount absorbed, or dose, is sufficient. The dose depends on the amount of agent
present (concentration) and the time exposed to the action (exposure time). The lower the
dose necessary for a substance to cause damage to the body, the greater its toxicity.
Since chemical agents differ in their physical and chemical properties, the effects they
produce are also different, these effects being of varying importance, from simple irritation
of the eyes and mucous membranes to cancer. Also
 Stability
The stability of medications in clinical practice is an area of interest due to its

repercussions on the healthcare organization of Pharmacy Services (SF) (centralization of
the preparation of more flexible and safe parenteral mixtures) and also due to its economic
impact by expanding the possibilities of incorporating the attribute of efficiency in these
areas. Furthermore, there are potential improvements in the quality of care derived from
stability studies when the results, in terms of clinical efficacy, are positive (analgesic
mixtures that improve pain control, changes in administration routes, etc.).
In general, the Pharmaceutical Industry does not usually extend stability studies after the
marketing of the drug, with only those required for its authorization and registration being
available (most laboratories do not provide stability data for more than 24 hours), which is
insufficient. in the context of centralized processing in the SFs to obtain maximum safety
and efficiency. Carrying out properly designed stability studies, basically following the
1-2
guidelines of the Pharmacopoeias and the standards of the International Committee on
3-7
Harmonization (ICH) , can make it possible to know and apply data on physical-
chemical and microbiological stability higher than that established by the Pharmaceutical
Industry and with a greater capacity for adaptation to daily care practice.
The FS or research groups made up of FS and centers with experience in stability studies,
which have the required analytical techniques at their disposal, carry out these studies, the
results of which are incorporated into clinical practice after their publication and analysis in
5
the scientific literature. The incorporation of complex molecules (proteins, monoclonal
antibodies, etc.) into the therapy, with a high economic cost, increases the possibility that
the study of the stability of these drugs will translate into significant savings for the health
system, but at the same time At the same time, the complexity of the required analytical
techniques increases.
In the field of oncohematology, in recent years, a large number of high-cost antineoplastic

drugs with stability data limited to a few hours or 24 hours at most have been registered
and incorporated into clinical practice, as indicated in their technical sheets ( table 1 ).
These stability times are clearly insufficient both for the FS and for the care organization of
the day hospitals or ambulatory care units where they are administered.
 Purity
. degree to which another chemical or biological entity is present in a substance, or to

which a drug is free of potentially harmful contaminants, including other active ingredients,
degradation products or synthesis byproducts, bacteria and other microorganisms.
 Pharmaceutical Equivalent
Pharmaceutical equivalents are defined by the WHO as those products that contain the
same amount of active ingredient, in the same pharmaceutical form, are intended to be
administered by the same route and meet identical or comparable quality standards 1.
This work is part of a project aimed at evaluating the pharmaceutical equivalence of those
medications that, due to their pharmacological implications and high consumption, require
the determination of this equivalence.
 Therapeutic Equivalent
It is one that meets the same or comparable quality specifications and that when
administered according to the conditions specified in its labeling, its effects, with respect to
efficacy and safety, are essentially the same, all determined by appropriate studies.
 Raw material
6
The raw materials for the pharmaceutical industry are the reagents, active ingredients,
catalysts, solvents and additives used in the production of drugs, medicines, and products
that contain nutritional supplements that contribute to health.

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Pharmacy Quality Assurance

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Pharmacy Quality Assurance

Students: Mariana Molina

 Definition of ISO Standards

ISO is the International Organization for Standardization, which regulates a series of

 Good Manufacturing Practices

Each pharmaceutical formulation is unique in its biopharmaceutical behavior, so the

In Chile, this system is not satisfactorily in place, as it is limited to the processing of

Currently, the standard that regulates pharmacovigilance in our country is Technical

 Good Storage and Distribution Practices

The stability of medications in clinical practice is an area of interest due to its

In the field of oncohematology, in recent years, a large number of high-cost antineoplastic

. degree to which another chemical or biological entity is present in a substance, or to

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