Quality Assurance and Quality

Management Concepts
Definitions, concept of QC, QA and GMP

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Learning Outcomes:
The learners will be able to
Know the various terms in Quality Assurance Subject
 Know the definitions of various terminologies in Quality
Assurance Subject

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 Some Definitions

ACTIVE PHARMACEUTICAL INGREDIENT

(API)
Any substance or mixture of substances intended to be
used in the manufacture of a pharmaceutical dosage
form and that, when so used, becomes an active
ingredient of that pharmaceutical dosage form. Such
substances are intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease or to
affect the structure and function of the body.

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standard operating procedure (SOP)
An authorized written procedure giving instructions for
performing operations not necessarily specific to a given
product or material (e.g. equipment operation, maintenance
and cleaning; validation; cleaning of premises and
environmental control; sampling and inspection). Certain
SOPs may be used to supplement product-specific master and
batch production documentation.
starting material
Any substance of a defined quality used in the production of a
pharmaceutical product, but excluding packaging materials.
validation
Action of proving, in accordance with the principles of GMP,
that any procedure, process, equipment, material, activity or
4 system actually leads to the expected results (see also
qualification).
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.
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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.
 QC INTERRELATIONSHIP

TQM

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 Developme DISTRIBUT
nt ION

Areas
of QA
INSPE
QC CTION
PRODU
CTION
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 Product meets
specifications To identify &’
& mfd as per prepare necessary
std. of GMP SOP’s to control
To ensure quality
quality policies
adopted by a Responsibiliti
company are es of QA
followed
Assess the operations
Responsibility of continually, advise,
quality guide for compliance of
monitoring or internal & external
audit function regulations

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Quality assurance framework
DOCUMENT REVIEW

INSPECTION OF LOCAL/IMPORTED PRODUCT SAMPLES, MANUFACTURING SITES, MARKET

PLACE

DATA DECISION
ANALYS MAKING &
IS AND ENFORCEMENT
EVALUA
PRODUCT TESTIING
TION

REPORTING

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 DETERMINANTS
OF
PHARMACEUTIC
AL QUALITY

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 PRACTICAL APPROACHES FOR QA

Procedure to establish comprehensive QA program

divided into 3:
1. Procedures to ensure that quality standard medicine
products are purchased. These are
Careful product selection
Careful supplier selection
Certificate of analysis for each batch of product
Certification of GMP
Batch certification (like WHO )
Inclusion of detailed product – quality specifications in
contract
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2. Procedures to verify that shipped goods meet
specifications:
Pre and post shipment inspection
Analytical Pharmaceutical testing
3. Procedures to monitor & maintain the quality of
pharmaceuticals from the moment they are received
until the medicine is finally consumed by the patient.:
Proper storage & distribution procedures
Appropriate dispensing
Instructions to the patient on proper use of medication
 Product defect and pharmacovigilance reporting
programs
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