2. CONCEPT OF QUALITY ASSURANCE
1. The manufacturer should be in a position:
2. Quality Assurance is the professional, social and legal responsibility for the assurance of product quality with the pharmaceutical
a. to control the sources of product quality variation, namely materials, machines, methods and men.
b. to ensure the correct and most appropriate manufacturing and packaging practices.
c. to assure that the testing results are in compliance with the standards or specifications.
d. to assure product stability and to perform other activities related to product quality through a well-organized total quality assurance
3.Most important goal of pharmaceutical industry is the implementation of an effective quality assurance policy.
4. Both quality assurance and quality control together assure the quality, safety and efficacy of pharmaceutical products.
3. QUALITY ASSURANCE
1. According to WHO Quality Assurance is the totality of the arrangements made with the
object of ensuring that pharmaceutical products are of the quality required for their
2. QA is the heart and soul of quality control QA = QC + GMP
Factors In Drug Quality Assurance
Import & Export Control
Labelling & Product Information
Qc & Analysis
Transport Distribution Dispensing
Manufacturing Processes &
Raw Materials Active & Inactive
Human Resources Professionals
Legislative Framework Regulations
Primary Functions of QA
1. Quality Control- Analytical testing of products.
2. Active and Non active material control- Sampling, inspecting and testing of incoming raw
3. Packaging and labeling components- Bottles, caps, foils, labels, measures, cartons.
4. Physical inspection of product and operations at critical intermediate stages- In-process
4. ELEMENTS OF THE QUALITY ASSURANCE CYCLE IN PHARMACEUTICAL
Research Development Prototyping Documentation
Raw Materials Facilities Equipment Personnel and Supervision
Monitoring, Feedback, Follow-up
A Guiding Philosophy for Quality Assurance in
Poor Quality Medicines:
1. Are a health hazard.
2. Waste money for governments and consumers.
3. May contain toxic substances that have unpredictable, unintended
4. Will not have a desired therapeutic effect.
5. Does not save anyone any money in the long term.
6. Hurt everyone – patients, health care workers, policy makers, regulators,
5. CONSEQUENCES OF Q.A. VIOLATION:
There are following consequences of violation of QA:-
1. High health bills
2. Loss of confidence in the Health Services.
3. Lot of Economic Losses.
4. National Security Issue.
5. Poor treatment outcomes.