In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical Quality Assurance is one of them.

1. THE ROLE OF QUALITY ASSURANCE
IN PHARMACEUTICAL INDUSTRY
DONE BY :
UNDER SUPERVISION OF : DR-SHEREN
Mahmoud Ashraf 140571
Safwat Hatem
Mahmoud Rashad

2. WHAT IS QUALITY
ASSURANCE ?
It is the Sum of Concepts that covering all matters that
influence the Quality of the products "individually or
collectively ".
It is A part of Quality Unit Which consists of
QA
GMP QC

3. WHAT IS PHARMACEUTICAL QUALITY ASSURANCE ?
The activities and responsibilities required to
ensure or assure that the medicine that
reaches the patient is safe, effective, and
acceptable to the patient .

4. RESPONSIBILITIES OF QUALITY ASSURANCE
The Responsibilities of
QA Unit is :
It has the authority for
dispositioning of all
production materials
“approval or rejection “.
It also assure all product
integrity ,potency ,purity
and stability of all aspect
that influence product
quality.

5. FACTORS IN DRUG QUALITY ASSURANCE
Quality of Drug
Manufacturin
g process
Raw-
materials
Human
Resources
professional
Storage
Packaging
Import
&Export
control
Transport&
Distribution
QC& Analysis