Lesson 2: Basic concepts of Quality Assurance and Quality Control

WHO stands for

World Health Organization

ISO stands for

International Organization for Standardization

GCM or cGMP stands for

Current Good Manufacturing Practice

SOP stands for

Standard Operating Procedure

USP stands for

United States Pharmacopeia

NF stands for

National Formulary

FDA stands for

Food and Drug Administration

IPQA stands for

In-Process Quality Assurance

What is “Quality Assurance” According to WHO

quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.

Quality assurance can be divided into major areas (5)

1. development

2. quality control

3. production

4. distribution

5. inspections.

ISO 9000

part of quality management focused on providing confidence that quality requirements will be fulfilled.

ISO 9000 defines quality control as

a part of quality management focused on fulfilling quality requirements.

QC: It is that part of GMP (Good Manufacturing Practice) concerned with (4)

1. sampling

2. specification & testing

3. documentation

4. release procedures