QUALITY

MANAGEMENT IN
PHARMACEUTICAL
INDUSTRY
Content
◦Quality
◦Quality control of pharmaceutical product
◦Total quality management (TQM)
◦Quality management in drug industry
◦Quality assurance
◦Good manufacturing practices (GMP)
◦Quality control
◦Comparison b/w QA and QC
◦Testing
◦Specifications
Quality
◦Word quality derived from Latin word ‘Qualitas’
meaning what kind
◦The totality of features and characteristics of a
medicinal product and its ability to satisfy stated or
implied need.
Quality control of pharmaceutical
products
◦It is a concept that cover all measures taken including the
setting of specifications, sampling, testing and analytical
clearance to ensure that raw material, intermediate,
packaging materials and finished pharmaceutical products
conform with established specifications for identity,
strength, purity and other characteristics.
Total quality management (TQM)
◦TQM can be defined as
The management of initiatives and procedures that are
aimed at achieving the delivery of quality product and
service.
◦TQM is an approach that seeks to improve quality and
performance which will meet or exceed customer
expectation.
Quality management in drug industry
◦Quality management is usually defined as the aspect of
management function that determines and implements the
“quality policy”,i.e. the overall intention and direction of an
organization regarding quality, as formally expressed and
authorized by top management.
◦It refers to all activities to ensure that the packaging , labelling ,
distribution , testing and whole selling of the drug comply with
requirement of marketing authorization do not place consumer
at risk due to inadequate safety and quality.
Basic elements of quality management
The basic elements of quality management are:
❑An appropriate infrastructure or “quality system”
❑Organizational structure, procedures, processes and resources
❑Systematic actions necessary to ensure adequate confidence that a
product (or service) will satisfy given requirements for quality.
❑The totality of these actions is termed “quality assurance”.
◦Within an organization, quality assurance serves as a
management tool.
◦The concepts of quality assurance, GMP and quality control
are interrelated aspects of quality management which
constitute three basic elements of quality management:
▪Q.A
▪GMPs
▪Q.C
QA

GMP

QC

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Quality assurance
◦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.
◦QA therefore incorporates GMP.
◦QA is a wide-ranging concept covering all matters
that individually or collectively influence the quality
of a product.
◦The system of quality assurance appropriate to the
manufacture of pharmaceutical products should ensure
that:
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).
Production and control operations are clearly specified in
a written form.
Managerial responsibilities are clearly specified in job
descriptions
Arrangements are made for the manufacture, supply and use of
the correct starting and packaging materials
All necessary controls on starting materials, intermediate
products, and bulk products and other in-process controls,
calibrations, and validations are carried out
The finished product is correctly processed and checked,
according to the defined procedures
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
There is a procedure for self-inspection and/or quality
audit that regularly appraises the effectiveness and
applicability of the quality assurance system
Deviations are reported, investigated and recorded
There is a system for approving changes that may have an
impact on product quality
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
 Components of quality assurance
◦Management
❖One of the most important component of QA
program in a laboratory are the comprehensive
management documents which should describe in
detail the management structure of the laboratory.
Training
◦It is important that all staff are adequately trained for
the task they have to perform also training must be
documented in order that management and other
personnel can verify that staff are competent to
conduct the duties required for them.
Laboratory facilities
◦Resources are require for regular laboratory work as
well as for the additional work load associated with
quality assurance
◦It is essential that these resources i.e space , staff ,
equipment's and supplies are sufficient for the
volume of work to be done.
Equipment maintenance and calibration
◦All equipment's must be maintained on regular basis
consistent with the documented criteria of the
laboratory.
◦The laboratory must apply standard which are well
within the limits normally established and
recommended for the care of the particular piece of
equipment.
Sampling
◦Procedures for sampling operation should be carefully documented
, clear details should be given for precaution to be taken while
sampling and sampling strategies to be employed
◦Careful documentation during sampling is required so that all
relevant information on the nature of sample (when it was taken,
where it was taken and under what condition it was taken) are
clearly recorded on site at the time of sampling by person
conducting the sampling.
Sample receipt , storage and disposal
◦Almost as important sampling is the proper storage
of samples prior to analysis it is important to ensure
that passage of a sample through laboratories and
analytical system is fully documented
◦Equally important are arrangements for the disposal
of sample
Reporting of results
◦The final products of the laboratory are the data that it reports
◦It therefore follows that the efforts of quality assurance are
directed towards seeing that these data are suitable for use in
an assessment.
◦This include the final stage of reporting and interpreting the
results which have been generated.
Good manufacturing practices (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 for prevention of
1. Cross-contamination
2. mix-ups (confusion) caused by, for example, false labels being
put on containers.
Under GMP:

◦All manufacturing processes are clearly defined,

systematically reviewed
◦Qualification and validation are performed
◦All necessary resources are provided
◦Instructions and procedures are written in clear language
◦ Operators are trained to carry out procedures correctly
◦Records are made (manually and/or by recording
instruments) during manufacture
◦Records covering manufacture and distribution, which
enable the complete history of a batch to be traced, are
retained in a comprehensible and accessible form
◦The proper storage and distribution of the products
minimizes any risk to their quality;
◦A system is available to recall any batch of product
from sale or supply;
◦Complaints about marketed products are examined,
the causes of quality defects investigated, and
appropriate measures taken in respect of the
defective products to prevent recurrence
Quality control

◦QC refers to a procedure or set of steps taken during the

manufacturing of a product or service to ensure that it meets
requirements and that the product/service is reproducible.
◦QC is that part of GMP concerned with sampling, testing,
documentation, and release procedures which ensure that the
necessary and relevant tests are performed and product is
released for use only after confirming its quality.
Comparison b/w QA and QC
Quality assurance Quality control
◦QA is the sum total of ◦ QC is that part of GMP which is
organized arrangements concerned with sampling,
made with the object of specifications, testing and with in
the organization, documentation,
ensuring that product will and release procedures which
be of the Quality required ensure that the necessary and
by their intended use. relevant tests are carried out
◦All those planned or ◦Operational laboratory
systematic actions techniques and activities
necessary to provide used to fulfill the
adequate confidence that requirement of Quality
a product will satisfy the
requirements for quality
◦QA is company based ◦QC is lab based
◦Focus on defect ◦Focus on identifying
preventing defects
◦It is process oriented ◦It is product oriented
Testing
◦Techniques used to determine that pharmaceuticals
conform to specified standards of identity, strength,
quality, and purity.
Testing Program and Method
◦Total quality assurance certifies that each received lot of raw
material or each manufactured batch of product meets the
established quality standards.
◦It provides for the authorization of the release of the approved
raw material for manufacturing, and the release of the
manufactured product to the market, based on actual
laboratory testing – physical, chemical, microbiologic, and at
times, biologic.
◦Most therapeutic agents are substances of
known chemical structure or composition and
can be assayed by quantitative
physicochemical means.
◦The standard purity statement for the active
ingredient in the dosage form usually permits
a wider variation than that for the active
ingredient itself.

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◦Through purity and identity tests, the quality
of the drug alone is established, and its level
of impurities restricted, as in the limiting tests
for chloride, sulfate, and heavy metals.
◦The assay measures the concentration of this
previously accepted drug in the dosage form.

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Physical and chemical test
◦ Tests for appearance, color, odor, identity, optical
rotation, specific gravity, pH, solubility, viscosity,
disintegration time, hardness, friability, average
weight or volume per unit, weight or volume
variation, content uniformity, dissolution profile,
particle size, moisture content, and assay for active
ingredient (s), impurities, contaminants, or
degradation products.

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Biologic tests
◦ Microbiologic or macrobiologic assays, and tests
for potency, safety, toxicity, pyrogenicity,
sterility, antiseptic activity, and antimicrobial
preservative effectiveness tests.

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◦When a physicochemical assay method is
not possible, a macrobiologic or
microbiologic procedure is employed.
◦Biologic testing of drugs may be
quantitative or qualitative in nature; it
utilizes intact animals, animal
preparations, isolated living tissues, or
microorganisms.

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◦Biologic methods are employed in the
following situations:
◦(1) when adequate chemical assay has not
been adevised for the drug substances,
although its chemical structure has been
established.
◦(2) when chemical structure of the drug
substance has not been fully elucidated.

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◦(3) when the drug is composed of a
complex mixture of substances of varying
structure and activity.
◦(4) when it is impossible or impractical to
isolate the drug from its interfering
substances, although the drug itself can be
analyzed chemically.

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◦(5) when the biologic activity of the drug substance
is not defined by the chemical assay.
◦(6) when specificity, sensitivity, or practically
dictates the use of biologic rather than chemical
assay procedures.

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Specifications
◦A specification (often abbreviated as spec) is an
clearly stated set of requirements to be satisfied by a
material, design, product, or service.
Types of Specifications
◦Specification writing for the pharmaceutical industry
are quite unique.
◦The main purpose of establishing specifications is to
ensure that the characteristic of the finished dosage
forms conform to appropriate standards of identity,
purity, potency, quality, safety and efficacy.

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The first four types of specifications i.e.
◦identity
◦purity
◦potency
◦Quality
are distinctively analytic in nature and are
embodied in specifications known as drug
standards.

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Reference
◦WHO good manufacturing practices : main principles for
pharmaceutical products
◦Internet