UNIT I

QUALITY ASSURANCE AND QUALITY

MANAGEMENT CONCEPTS
The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since
its inception. The setting of global standards is requested in Article 2 of the WHO Constitution,
which cites as one of the Organization’s functions that it should “develop, establish and promote
international standards with respect to food, biological, pharmaceutical and similar products.”
Different regulatory bodies make sure that products are as per the requirements of stringent
specifications and meet the demands of the customer.

Such regulatory bodies include: USFDA, WHO, UNICEF,

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 DEFINATIONS

Quality Control (QC) is a system of routine technical activities, to measure and control the
quality of the product as it is being developed. It involves removal of identifiable cause of defects and variations from
the set of standards.
The QC system is designed to:
(i) Provide routine and consistent checks to ensure manufactured product or performed service adheres to defined set
of quality criteria.;
(ii) Identify and address errors and omissions;
(iii) Documentation and maintenance of record of all QC activities.
QC activities include general sections such as finished product(segregated on the basis of market), raw materials,
validation, stability, microbiology, which involve accuracy checks on data acquisition and calculations and the use of
approved standardised procedures for emission calculations, measurements, estimating uncertainties, archiving
information and reporting. Higher tier QC activities include technical reviews of source categories, activity and
emission factor data, and methods.
Quality Control (QC)

Raw Material

Finished Product

Validation

Stability

Microbial Testing

Packaging

QC Documentation and Regulatory

 Testing Documentation

Sampling Reporting

Process control, Control charts, Acceptance sampling, and Product quality control testing.
STEPS in process of QC

 Establishing quality standards in terms of size, design, durability appearance etc on the basis of customers

preferences and cost of production.

 Selecting the manufacturing process; which permits output of the required specifications.

 Development of measurement techniques to ensure whether production confirms to set of specifications or not.

 Monitoring the product quality which requires designing a system of periodical checks of the end product to find

out deviations from set standards of a quality and locating causes of such deviations.

 Taking corrective actions to remove the causes of deviations.

SIGNIFICANCE OF QUALITY CONTROL
Cost reduction and profit maximization
Increase in operational efficiency (performance of raw materials, men,

machines)

Maximum customer satisfaction

Good will image of enterprise
Insurance against heavy losses
Promotes employees Productivity.
Quality assurance

It 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 incorporates GMP and other factors, including those outside the scope of this

guide such as product design and development.

 Pre production
inspection
 During production
 Pre shipment
inspection
 Container
loading/Unloading
inspection.
AND
APQR Preparation
(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

(c)GMP requirements are adopted;

(d) managerial responsibilities are clearly specified in job descriptions;

(e) arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;

(f) all necessary controls on starting materials, intermediate products, and bulk products and other in-process

controls, calibrations, and validations are carried out;

(g) the finished product is correctly processed and checked, according to the defined procedures;
(h) 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;
(i) 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.
(j)there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and
applicability of the quality assurance system;
(k) deviations are reported, investigated and recorded;
(l) there is a system for approving changes that may have an impact on product quality;
(m) 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.
(n) There is a system for quality risk management.
QRM
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. GMP are aimed primarily at diminishing the
risks inherent in any pharmaceutical production.

Such risks are essentially of two types: cross-contamination (in particular

of unexpected contaminants) and mix-ups (confusion) caused by, for
example, Due to false labels being put on containers.
All employees should take GMP training to
assess their performance and to understand All products should be
their roles and responsibilities. tested and quality
Company should recruit QP/RP assurance performed
before distributing to
consumers.
Premises should be cleaned Manufacturers should
to eliminate fatalities, ensure that raw materials
cross-contamination, and including ingredients,
accidents. All equipment processing aids, and
should be calibrated and packaging materials must
maintained in good have clear specifications at
working condition to avoid the time of production.
the risk of equipment
breakdown.

A procedure is a set of
guidelines and rules to follow in Journey of Processes should be
the business to achieve a documented, uniform, precise,
consistent result for undertaking and circulated to all employees.
any process. Should be complied by all
Product’s outline from end to end with employees.
step-by-step instructions.
(a) all manufacturing processes should be clearly defined, systematically reviewed in
the light of experience, and shown to be capable of consistently manufacturing
pharmaceutical products of the required quality that comply with their specifications;
(b) qualification and validation should be performed;
(c) all necessary resources should be provided, including:

(i) appropriately qualified and trained personnel;

(ii) adequate premises and space;
(iii) suitable equipment and services;
(iv) appropriate materials, containers and labels;
(v) approved procedures and instructions;
(vi) suitable storage and transport;
(vii) adequate personnel, laboratories and equipment for in-process controls;
(d) instructions and procedures should be written in clear and unambiguous language,
specifically applicable to the facilities provided;

(e) operators should be trained to carry out procedures correctly;

(f) records should be made (manually and/or by recording instruments) during

manufacture to show all steps required by the defined procedures and instructions have
in been taken and quantity and quality of the product are as expected; any significant
deviations are fully recorded and investigated;

(g) records covering manufacture and distribution, which enable the complete history
of a batch to be traced, should be retained in a comprehensible and accessible form;
(h) the proper storage and distribution of the products should be done to minimize any
risk to their quality;
(i) a system is available to recall any batch of product from sale or supply;

(j) complaints about marketed products should be examined, the causes of quality
defects investigated, and appropriate measures taken in respect of the defective
products to prevent recurrence.
 ISO
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

The International Organization for Standardization is an independent, non-governmental, international

standard development organization composed of representatives from the national standards
organizations of member countries
STAGES
STAGES Cont….
ISO 9000 series aims management of overall quality standards
of organization c
STANDARD OBJECTIVES
(ISO 9000) Quality management and quality assurance standards—
Guidelines for selection and use Quality systems

(ISO 9001) Model for quality assurance in design/ development,

production, installation and servicing

(ISO 9002) It has 18 elements covering production and installation. It is

same as ISO 9001 without the first two tasks viz design and
development.

(ISO 9003) It has 12 elements covering final inspection and testing for
laboratories and warehouses etc.
(ISO 9004) This provides guidelines to interpret the quality management
and quality assurance. This also has suggestions which are not
mandatory.
BENEFITS OF ISO 9000 SERIES
ISO 14000 series aims management of environmental effects of
an organization.
STANDARD OBJECTIVES
(ISO 14001) Specifications of environmental management systems
(ISO 14004) Guideline standard

ISO 14010 through ISO 14015 Environmental auditing and related activities

ISO 14020 through ISO 14024 Environment Labelling

ISO 14031 through ISO 14032 Environmental Performance Evaluation.

ISO 14040 through ISO 14043 Life cycle Assessment

ISO 14050 Terms and Definations