WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 11): Materials: Materials

WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 11): Materials
(2006; 25 pages)

Table of Contents

Materials

Objectives

To review specific requirements for each type of material:

- Starting materials

- Packaging materials

- Intermediate and bulk products

- Finished products

- Rejected and recovered materials

- Recalled products

- Returned goods

- Reagents and culture media

- Reference standards

- Waste materials

- Miscellaneous materials
To examine (in groups) the problems associated with materials, and how to overcome them

Our main objective in this session is to review with you all the key issues relating to materials mentioned in the WHO GMP text, Part One. First of all, we will be discussing the general principles of GMP for materials. We will then review in turn different materials including:

Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected and recovered materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
Miscellaneous materials.

We will then have a group discussion where we will be looking at specific issues and problems relating to materials, that you may encounter during your inspections.