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 Good Manufacturing Practices (GMP)
management technique used to • Performance standards that WHO and
communicate to employees what is many national governments
required to produce the desired established for pharmaceutical
quality of products and services and manufacturers covering, for example,
to influence employee actions to personnel, facilities, packaging, and
complete tasks according to the quality control.
quality specifications.
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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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