Basic Concepts of Quality Assurance & Management

Quality
Assurance &
Management
Basic Concepts And
Ideas
Anirban Saha
M.Pharm (Pharmaceutics)
Year- 1st , Semester- 2
Amity University.
AMITY INSTITUTE
OF PHARMACY

Outline
o Definitions.
o Quality & Its Importance.
o Introduction.
o Characteristics of QA Programme.
o How is quality assessed and assured ?
o Quality Management And its Systems.
o Quality Assurance for Excipients.
o Quality Assurance for API.
o Quality Assurance Of Packing Materials.
o Some general tests of packing materials.

Quality Assurance (QA)—Sum of all activities and
responsibilities required to ensure that the medicine that
reaches the patient is safe, effective, and acceptable to
the patient
Quality Control (QC)—Process concerned with
medicine sampling, specifications, and testing, and with
the organization’s release procedures that ensure that
the necessary tests are carried out and that the materials
are not released for use, nor products released for sale
or supply, until their quality has been judged satisfactory
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3

Quality Management (QM)—
A quality management system is a management technique
used to communicate to employees what is required to
produce the desired quality of products and services and to
influence employee actions to complete tasks according to
the quality specifications.
Good Manufacturing Practices (GMP)—
Performance standards that WHO and many national
governments established for pharmaceutical manufacturers
covering, for example, personnel, facilities, packaging, and
quality control.
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Quality is “totality of characteristics of an entity that
bear on its ability to satisfy stated and implied needs”.
o The ability to make the same thing the same way,
over and over again.
o Customer buys today is same as what they
bought last week or will buy next week.
o Product meets customer’s expectations 100% of
the time.
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Business success may simply be the extent to which
any organization can produce a higher-quality
product or service than its competitors are able to do
at a competitive price.
When quality is the key to a company’s success,
Quality Management system allow organizations
to:
o Keep up with and meet current quality levels.
o Meet the consumer’s requirement for quality.
o Retain employees through competitive
compensation programs.
o Keep up with the latest technology.
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Introduction:
Goals of QA Programs:-
 To make certain that each medicine reaching a
patient is safe, effective, and of standard quality.
 Obtaining quality products that are safe and effective
through structured selection and procurement methods
 Maintaining quality products through the appropriate
storage, distribution, monitoring, and use by
prescribers, dispensers, and consumers
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Characteristics of a QA Program
o Medicines are selected on the basis of safety and
efficacy, in an appropriate dosage form with the
longest shelf life.
o Suppliers with acceptable quality standards are
selected.
o Medicines received from suppliers and donors are
monitored to meet quality standards.
o Medicine packaging meets contract specifications.

o Repackaging activities and dispensing practices
should maintain quality.
o Adequate storage conditions in all pharmaceutical
areas are maintained.
o Transportation conditions are adequate.
o Product quality concerns are reported and
monitored.
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o INSPECTION of raw materials and API
on arrival.
• Visual inspection
• Product specification review (including expiry dates)
o LABORATORY TESTING for compliance with
pharmacopoeial standards.
• International Pharmacopoeia
• European Pharmacopoeia
• U. S. Pharmacopeia
• British Pharmacopoeia
• National Pharmacopoeia
o BIOAVAILABILITY DATA
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11

o Product selection
• Long shelf-life.
• Acceptable stability.
• Acceptable bioavailability.
o Selection of appropriate suppliers
• Supplier pre-qualification.
• Request samples from new suppliers.
• Request specific reports and data for certain medicines (e.g.,
bioavailability and stability studies).
• Collect and maintain information on supplier performance.
o Product certification
• GMP certificate of manufacturer.
• Product/batch certification (COA).
• Random local testing.
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06.01.2015 13
How Is Quality Assured?
Some other aspects:-
• Appropriate storage, transport, dispensing, and use
procedures.
• Pharmaceutical distribution and inventory control
procedures.
• Provision for appropriate storage and transport
including adequate temperature control, security,
and cleanliness.
• Avoidance of repacking unless quality control is
required

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Who Ensures Medicine Quality?
Drug Regulatory Authority
Medicine
Quality
 Physicians
and other
prescribers
 Drug and
Therapeutics
Committee
 Hospital
procurement
office
 Pharmacy
(and dispensers)
 Patients
Medicine
Quality
 Physicians
and other
prescribers
 Drug and
Therapeutics
Committee
 Hospital
procurement
office
 Pharmacy
(and dispensers)
 Patients

What Purpose Does a Quality Management System
Serve?
✔ Establishes a vision for the employees.
✔ Sets standards for employees.
✔ Builds motivation within the company.
✔ Sets goals for employees.
✔ Helps fight the resistance to change within
organizations.
✔ Helps direct the corporate culture.
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o ISO 9000 is a series of quality management systems
(QMS) standards created by the International
Organization for Standardization, a federation of 132
national standards bodies.
o The ISO 9000 QMS standards are not specific to
products or services, but apply to the processes that
create them.
o The standards are generic in nature so that they can be
used by manufacturing and service industries anywhere
in the world.
o An organization that would like to have ISO certification
needs to meet all the criteria stated in the ISO standards
and pass a detailed audit performed by an ISO auditor.
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06.01.2015 17
Fundamental elements for effective
pharmaceutical quality systems are as follows:
• Managerial review of process performance
and product quality.
• Process performance and product quality
monitoring system.
• Corrective action and preventive action
(CAPA) system.

Management responsibility:
Leadership is essential to establish and maintain a company-wide
commitment to quality and for the performance of the pharmaceutical
quality system. Management has the responsibility to achieve quality
related goals as per the quality policy.
o There must be a clear understanding and unambiguous set of
authority and responsibility at all levels including individual and
collective role.
o Strict commitment toward the quality objectives should be
demonstrated.
o Management should participate in the design, implementation,
monitoring, and maintenance of an effective pharmaceutical quality
system.
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Continuous improvement in process performance
and product quality:
o Product quality depends on appropriate design of quality
attributes during product development phase.
o Technical knowledge or specification, control strategy and
validation approaches should be effectively transferred within
or between manufacturing sites for commercial
manufacturing.
o Product discontinuation aspects include retention of relevant
documents, samples and review of product assessment,
complaint handling and stability related problems as per
regulatory provisions.
06.01.2015 19

What Is the Need for Quality Assurance of Excipients?
o Excipients Need to be Safe and Provide
Consistent Quality including Performance.
o Excipients must be manufactured in
accordance with CGMP.
o Drugs are approved with the premise that
excipients used in exhibit batches are going to
remain consistent while the drug is on the
market.
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o The amount of excipients quite often exceeds the
amount of API in any given drug.
o Excipient purity is difficult to determine for many
excipients.
• –Heterogeneity of the chemical composition is
common for many excipients whereby the excipient
is still considered to be a “pure drug substance”
• –Test methods often fail to account for anywhere
near 98%, whereas we generally regard 2.0% to be
the upper limit for substances regarded as
unnecessary if not deleterious to safety or efficacy
of a drug.
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o Globalization and Cost Pressures Have Changed
the Playing Field
• Greater uncertainty about integrity of supply chain.
• Confirmed incidents involving intentional
adulteration suggesting the risk, as far as the US
supply chain, has increased.
• Pressure leading to shortcuts and risk taking which
might not be in best interest of patient safety.
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Quality assurance is a wide-ranging concept that
covers all matters that individually or collectively
influence the quality of an API. It is the total of the
organized arrangements made with the objective
of ensuring that APIs are of the quality required
for their intended use. Quality assurance therefore
incorporates GMP, along with other factors that
are outside the scope of these guidelines.
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A system of quality assurance appropriate for the fabrication,
packaging, labelling, testing, distribution, importation, and
wholesale of APIs should ensure that:
o APIs are designed and developed in a way that takes
into account the GMP requirements.
o Each fabricator should establish, document, and
implement an effective system for managing quality
that involves the active participation of management
and appropriate manufacturing personnel. Managerial
responsibilities should be clearly specified.
o Systems, facilities and procedures are adequate and
qualified, whether they are new or modified;
o Production and control operations are clearly
specified.
o Analytical methods and critical processes are
validated.
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o Arrangements are made for the supply and use of the
correct raw and packaging materials.
o All necessary control on APIs and any other in-process
monitoring is carried out.
o Outsourced activities are subject to appropriate controls
and meet GMP requirements.
o Fabrication, packaging/labelling, testing, distribution,
importation, and wholesaling are performed in accordance
with established procedures.
o APIs are not released for sale or for further fabrication
before the authorized person from the quality control
department has approved that each lot has been produced
and controlled in accordance with the approved
specifications.
o Satisfactory arrangements exist for ensuring that the APIs
are stored, distributed, and subsequently handled in such a
way that quality is maintained throughout their expiry or
retest date.
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Any company that sells or distributes packaging,
packaging components, or packaged products is
responsible for compliance with state toxics in
packaging laws, regardless of where the
regulated metals originated. Based on the
experiences of regulated entities, it has become
very clear that packaging specifications and the
assurance of suppliers are not always enough to
ensure the quality of packaging materials.
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o Keep records of pack specs. agreed with
suppliers.
o Keep examples of previously supplied,
acceptable packs, for reference & comparison.
o Employ basic measuring methods to check pack
dimensions/weights/compressive strength, etc.
o Maintain close relations with pack suppliers,
exchanging & comparing QA findings.
o Have access to specialist QA & test services
with regard to particular pack materials &
problems.
06.01.2015 27

Strength tests:
-Bursting strength (Mullen; tests drop resistance).
-Edge crush (tests rigidity, stacking strength).
-Flat crush (tests compression resistance).
-Puncture (tests resistance to puncturing/shocks).
Other tests:
-Adhesion tests (adhesion of paper plies and of
liners to fluting).
-Moisture resistance (Cobb; water absorption
test).
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•Tensile test & stretch/elongation test.
•Tear test, machine & cross direction (Elmendorf
test).
•Moisture vapour transmission test.
•Gas permeability tests (oxygen, CO2, odours).
•Resistance to product, solvents, oils and
greases.
•Heat and cold (re filling temperatures, etc.);
climatic and ageing tests.
•Heat sealing strength tests.
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•Pressure testing.
•Leakage testing.
•Closure/seal testing (including closing
torque/ease of opening).
•Compression testing.
•Drop testing.
•Climatic (temperature & humidity)
testing/accelerated ageing.
06.01.2015 30

•Print rub/scuff resistance/adhesion tests.
•Resistance to product constituents/solvents.
•Registration accuracy/uniformity.
•Print definition/clarity/legibility.
•Colorimetric accuracy/consistency of tones and
shades (compared to reference colour samples).
•Resistance to fading (accelerated ageing test).
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•Compression/top load tests (empty & filled
packages).
•Leakage/seal/closure failure tests.
•Simulated transit tests with filled packages: drop
test; vibration test; inclined plane impact test;
revolving drum test; humidity and temperature
resistance tests.
•Accelerated aging tests.
06.01.2015 32

www.ncbi.nlm.nih.gov/pubmed/19289341
www.fda.gov
www.fda.gov/downloads/ICECI/ComplianceManuals/.../UCM125
420.pd
Quality Assurance Of Drugs in Pharmaceuticals, P.D.Sethi,
Vandana Publ, New Delhi.
Quality Assurance of Pharmaceuticals: A Compendium of
Guidelines and Related Materials. Good manufacturing
practices and inspection, Volume 2, WHO.
06.01.2015 33

Basic Concepts of Quality Assurance & Management

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