NAME: Anoosha Farooqui

CLASS: 4th year (7th Semester)

DEPARTMENT: Pharmacy
ROLL NO.: 501-S19-001
SUBJECT: Pharmaceutics VI-A
(Pharmaceutical Quality Management)
COURSE CODE: PHARM 614
Cr. Hr.: 3+1
SUBMITTED TO: Sir Maharaja
DATE OF SUBMISSION: 12th March 2022
TOPIC: Standardization of pharmaceuticals
(QA system adopted in pharmaceutical industry,
GMP)
CONTENTS:
Standardization of pharmaceuticals Pg. no.01
Definition

Quality assurance Pg. no.01-04

Definition
Aim
Goal
Responsibility
Tool example
Principles

Quality assurance system Pg. no. 04-06

Definition
Features
PQS and QA
Applications

Good manufacturing practice: Pg. no. 06-09

Definition
Principles
importance
Requirements

SOPs Pg. no. 10

Definition
Types of SOPs
Conclusion and references Pg. no. 10
ABSTRACT:
Quality Assurance (QA) covers all aspects that could have an impact on the quality of
prescribed pharmaceutical products. This article focuses on some of the Pharmaceutical
Quality Systems in relation to QA of manufactured medicines. The main objective is to
learn about standardization of pharmaceuticals, quality assurance, quality assurance
system adopted in pharmaceutical industry and Good manufacturing practice (GMP).

STANDARDIZATION OF PHARMACEUTUCALS:
DEFIINITION:
Standardization of pharmaceuticals means confirmation of its identity and
determination of its quality and purity. The quality control standards of various
medicinal plants, used in indigenous system of medicine, are significant nowadays in
view of commercialization of formulations based on medicinal plants.
Standardization is a numerical value or specific property that quantifies the purity and
quality of drugs and formulations.
The process of defining and applying the conditions to ensure that a given range of
requirements can normally be met with a minimum of variety and in reproducible and
economic manner on the basis of the best techniques.

QUALITY ASSURANCE:
DEFINITION:
QA is a set of activities for ensuring quality in the
processes by which products are developed.
Quality assurance is a wide-ranging concept
covering all matters that individually or
collectively influence the quality of a product. It
is the totality of the arrangements made with
the object of ensuring that pharmaceutical
products are of the quality required for their
intended use. Quality assurance therefore

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incorporates GMP and other factors, including those outside the scope of this guide
such as product design and development.

AIM OF QA:
QA aims to prevent defects with a focus on the process used to make the product. It is a
proactive quality process.

GOAL OF QA:
The goal of QA is to improve development and test processes so that defects do not
arise when the product is being developed.

HOW:
Establish a good quality management system and the assessment of its adequacy.
Periodic conformance audits of the operations of the system.

WHAT:
Prevention of quality problems through planned and systematic activities including
documentation.

RESPONSIBILITY OF QA:
Everyone on the team involved in developing the product is responsible for quality
assurance.

EXAMPLE OF QA:
Verification is an example of QA.

STATISTICAL TOOLS AND TECHNIQUES:

Statistical Tools & Techniques can be applied in both QA & QC. When they are applied to
processes (process inputs & operational parameters), they are called Statistical Process
Control (SPC); & it becomes the part of QA.

TOOL:
QA is a managerial tool.

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PRINCIPLES:
The system of quality assurance appropriate to the manufacture of pharmaceutical
products should ensure that:
(a) Pharmaceutical products are designed and developed in a way that takes account of
the requirements of GMP and other associated codes such as those of good laboratory
practice (GLP) and good clinical practice (GCP);
(b) Production and control operations are clearly specified in a written form and GMP
requirements are adopted;
(c) Managerial responsibilities are clearly specified in job descriptions;
(d) Arrangements are made for the manufacture, supply and use of the correct starting
and packaging materials;
(e) All necessary controls on starting materials, intermediate products, and bulk
products and other in-process controls, calibrations, and validations are carried out;
(f) The finished product is correctly processed and checked, according to the defined
procedures;
(g) Pharmaceutical products are not sold or supplied before the authorized persons
have certified that each production batch has been produced and controlled in
accordance with the requirements of the marketing authorization and any other
regulations relevant to the production, control and release of pharmaceutical products;
(h) Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical
products are stored by the manufacturer, distributed, and subsequently handled so that
quality is maintained throughout their shelf-life;
(i) There is a procedure for self-inspection and/or quality audit that regularly appraises
the effectiveness and applicability of the quality assurance system;
(j) Deviations are reported, investigated and recorded;
(k) There is a system for approving changes that may have an impact on product quality;
(l) Regular evaluations of the quality of pharmaceutical products should be conducted
with the objective of verifying the consistency of the process and ensuring its
continuous improvement. The manufacturer must assume responsibility for the quality
of the pharmaceutical products to ensure that they are fit for their intended use, comply

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with the requirements of the marketing authorization and do not place patients at risk
due to inadequate safety, quality or efficacy. The attainment of this quality objective is
the responsibility of senior management and requires the participation and
commitment of staff in many different departments and at all levels within the
company, the company’s suppliers, and the distributors. To achieve the quality objective
reliably there must be a comprehensively designed and correctly implemented system
of quality assurance incorporating GMP and quality control. It should be fully
documented and its effectiveness monitored. All parts of the quality assurance system
should be adequately staffed with competent personnel, and should have suitable and
sufficient premises, equipment, and facilities.

QUALITY ASSURANCE SYSTEM ADOPTED IN PHARMACEUTICAL INDUSTRY:

Formal Structures or techniques to make sure products and services consistently meet
the standard required by the customer; quality systems may be validated either within
your organization, or by external auditors or by both. The basic steps followed to
implement system for an organization are:
 Develop the system
 Document it
 Inform, instruct and train the staff to use it.

FEATURES OF QUALITY ASSURANCE SYSTEM

 Pharmaceutical products are designed and developed in a way that takes account of
the requirements of GMP and other associated codes such as those of good laboratory
practice (GLP) and good clinical practice (GCP).
 All necessary controls on starting materials, intermediate products, and bulk products
and other in process controls, calibrations and validations are carried out.
 The finished products are correctly processed and checked according to the defined
procedures.
 Satisfactory arrangements exist to ensure, that the pharmaceutical products are
stored by the manufacturer, distributed and subsequently handled. There is a procedure
for self-inspection.
 Deviation are reported, investigated and recorded
 There is a system for approving changes that may have an impact on product quality.

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 Regular evaluations of the quality of pharmaceutical products should be conducted.

PHARMACEUTICAL QUALITY SYSTEMS (PQS) & QUALITY ASSURANCE (QA)

Pharmaceutical Quality Systems (PQS) consist of eight pillars, which are designed to
provide high quality finished pharmaceutical products, with QA and PQS working
together in synergy. Pharmaceutical companies strive to provide high quality products
to enable them to enhance their reputation, maximize profit and to provide high quality
drugs to humans and animals. To meet these targets, they rely on well-designed PQS,
which involve the coordination of quality through processes, with the aim of producing
finished products of the highest quality.

Figure 1: Eight Quality Systems contribute to the high quality of the finished
pharmaceutical product

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THE APPLICATION OF A PROCESS PERFORMANCE AND PRODUCT QUALITY
MONITORING SYSTEM THROUGHOUT THE PRODUCT LIFECYCLE.
The application of a process performance and product quality monitoring system
throughout the product lifecycle is shown in Table 1. This illustrates the most effective
monitoring system that provides assurance of the continued capability of processes and
controls to produce a product of desired quality and to identify areas for continual
improvement, according to PQS Q10.

GOOD MANUFACTURING PRACTICE (GMP):

Nevertheless, it is not possible to mention high quality finished pharmaceuticals without
mentioning Good Manufacturing Practice (GMP) and Validation. It is well known that all
manufacturing stages need quality assurance actions to ensure successful results; but
how can they be achieved, and which is the most important action during all the
manufacturing stages?
The answers can be found by applying GMP in each step of the manufacturing
process. GMP is part of Quality Management that ensures products are consistently
produced and controlled to the quality standards appropriate to their intended use and
as required by the marketing authorization or product specification. Furthermore, it
ensures the manufactured products meet the end-user’s needs in terms of safety,
quality and efficacy. GMP involves monitoring of processes, equipment, personnel and
the environment in pharmaceutical companies.

DEFINITION OF GOOD MANUFACTURING PRACTICE (GMP):

Good manufacturing practice is that part of quality assurance which ensures that
products are consistently produced and controlled to the quality standards appropriate
to their intended use and as required by the marketing authorization.

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Good manufacturing practices are the sets of the principles, regulations, codes (law or
official standard), guidelines and procedures and part of quality assurance system which
must be followed by the manufacturers to ensure that the products that are
consistently produce are of quality standard and appropriate for their intended use and
cover the manufacturing and testing of pharmaceutical dosage form and active
pharmaceutical ingredients, diagnostics, foods, various other pharmaceutical products
and medical devices GMP Principles: Good manufacturing practice guidelines provides
guidance for manufacturing, testing, and quality assurance in order to ensure that drug
product is safe for human consumption. Many countries have legislated that
pharmaceutical and medical device manufacturer must follow GMP procedures, and
have created their own GMP guidelines that correspond with their legislation.
GMP is essential in all cases from initial drug trials to commercial launch. To obtain the
best product, a manufacturer needs a system in place to ensure regular formulation,
processing and composition. Without regulation of a manufacturing process, the
consequences cause confusion that might escape notice in the first instance but at some
later point will invalidate the safety of the product. This means someone will get
harmed or it will cost the manufacturer money. However, the importance of patient
safety is what drives companies to improve quality and prevent unnecessary
expenditure on manufacturing.
GMP applies to all types of pharmaceuticals. For example, a ‘standard product’ is one in
which the unit operation and risk assessment of the end product suggests simple
equipment ambient conditions; however, this doesn’t mean that the system can be
abused. GMP should be applied, and the product manufactured, according to highly-
regimented and regulated procedures. On the other hand, sterile medicines require
different processes and equipment. These types of manufacturing processes often
include biotechnology derivatives; where the consistency and potency of bio-
preparation, that needs validation and constant monitoring, is often highly variable but
may also be associated with issues such as purity. Sterile manufacture tends to be more
vigorous in terms of equipment and specialized clean rooms. These specialized
conditions and the nature of the drug itself often require additional staff training and a
stronger reliance on the Qualified Person (QP) to sign-off.

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PRINCIPLES:
All guidelines follow a few basic principles:
 Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic
manufacturing area.
 Controlled environmental conditions in order to prevent cross contamination of drug
product from other drug or extraneous particulate matter which may render the drug
product unsafe for human consumption
 Manufacturing processes are clearly defined and controlled. All critical processes are
validated to ensure consistency and compliance with specifications.
 Manufacturing processes are controlled, and any changes to the process are
evaluated. Changes that have an impact on the quality of the drug are validated as
necessary.
 Instructions and procedures are written in clear and unambiguous language.
Operators are trained to carry out and document procedures.
 Records are made, manually or by instruments, during manufacture that demonstrate
that all the steps required by the defined procedures and instructions were in fact taken
and that the quantity and quality of the drug was as expected. Deviations are
investigated and documented.
 Records of manufacture that enable the complete history of a batch to be traced are
retained in a comprehensible and accessible form.
 The distribution of the drugs minimizes any risk to their quality.
 A system is available for recalling any batch of drug from sale or supply.
 Complaints about marketed drugs are examined, the causes of quality defects are
investigated, and appropriate measures are taken with respect to the defective drugs
and to prevent recurrence

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WHY GMP IS ESSENTIAL?
GMP is essential due to two main reasons:
a) Initially: to assure the quality of the medicinal products.
b) Ultimately: to ensure the safety, wellbeing and protection of the patients.
The objective of GMP is to satisfy the following of a quality product:
 Safety
 Stability
 Potency
 Acceptability
 Efficacy
 Regulatory compliance

BASIC REQUIREMENT OF GMP WHO (Guidelines):

The following are the basic requirements of GMP and are clear guidelines and
instruction in good manufacturing procedures (GMP) about the requirements:
1. Quality management
2. Personnel and training
3. Personnel hygiene and sanitation
4. Premises and equipment
5. Documentation (including contamination control)
6. Quality control (including GLP, retained samples, stability study etc.)
7. Contact manufacturing and analysis
8. Product complaints, product recall and returned products.
9. Self-inspection and quality audits
10. Validation

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STANDARD OPERATING PROCEDURES (SOPS):
"A Standard Operating Procedure is a document which describes the regularly recurring
operations relevant to the quality of the investigation. The purpose of a SOP is to carry
out the operations correctly and always in the same manner. A SOP should be available
at the place where the work is done".
A SOP is a compulsory instruction. If deviations from this instruction are allowed, the
conditions for these should be documented.

TYPES OF SOPS:
 Fundamental SOPs: These give instructions how to make SOPs of the other categories.
 Methodic SOPs: These describe a complete testing system or method of investigation.
 SOPs for safety precautions.
 SOPs for operating instruments, apparatus and other equipment.
 SOPs for analytical methods.
 SOPs for the preparation of reagents.
 SOPs for receiving and registration of samples.
 SOPs for Quality Assurance.
 SOPs for archiving and how to deal with complaints.

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CONCLUSION:
It is concluded that, in pharmaceutical manufacturing, QA is the parameter used to
ensure prescribed medicine effectively produces the desired effect on the person taking
it. The PQS, part of QA system, was designed to help manufacturers achieve the target
for high quality finished pharmaceutical products; leading to the required level of drug
regulations and providing efficacy and safety for patients. The parameters for
approaching these targets include:
 The pharmaceutical product is designed to meet the need and performance
requirements.
 The process is designed to consistently meet product critical quality attributes 8
 Processes, equipment, personnel and deviations are identified and controlled in
an appropriate manner
 The whole manufacturing process is constantly monitored and updated to enable
consistency in quality over time.
The application of Pharmaceutical Quality Systems in pharmaceutical products can
extend to pharmaceutical development, which should facilitate innovation and
continual improvement of prescribed medication. It is the tool with which to achieve
product realization by designing, planning, implementing, maintaining and continuously
improving a system, to allow the consistent delivery of pharmaceuticals with
appropriate quality attributes

REFERENCES:
ARTICLES:
 https://www.researchgate.net/publication/
259795592_Quality_Assurance_Quality_Control_and_GMP_for_Pharmaceutical_Products
 https://www.europeanpharmaceuticalreview.com/article/78981/quality-assurance-quality-systems-
making-medicinal-products/

BOOKS
 Adnan’s Pharmaceutical quality management
 Quality assurance of pharmaceuticals

WEBSITES:
 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3523529/#:~:text=Standardization%20of%20drugs
%20means%20confirmation,formulations%20based%20on%20medicinal%20plants.

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