1. CONCEPT OF
QUALITY
ASSURANCE
MADE BY KASHISH WILSON
ASSISTANT PROFESSOR
MMCP,MM(DU) MULLANA AMBALA

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
manufacturers.
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
system.
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
intended use.
2. QA is the heart and soul of quality control QA = QC + GMP
Quality
Management
Quality
Assurance
GMP
Quality
Control
Factors In Drug Quality Assurance
Drug
Product
Quality
Import & Export Control
Packaging
Labelling & Product Information
Qc & Analysis
Transport Distribution Dispensing
& Use
Storage
Manufacturing Processes &
Procedures
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
materials.
3. Packaging and labeling components- Bottles, caps, foils, labels, measures, cartons.
4. Physical inspection of product and operations at critical intermediate stages- In-process
controls.

4. ELEMENTS OF THE QUALITY ASSURANCE CYCLE IN PHARMACEUTICAL
MANUFACTURING
Research Development Prototyping Documentation
Raw Materials Facilities Equipment Personnel and Supervision
Monitoring, Feedback, Follow-up
Research
Development
Documentatio
n
Raw Materials
Facilities
Equipment
Personnel
A Guiding Philosophy for Quality Assurance in
the
Pharmaceutical Industry:
Poor Quality Medicines:
1. Are a health hazard.
2. Waste money for governments and consumers.
3. May contain toxic substances that have unpredictable, unintended
consequences.
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,
manufacturers.

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.