WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 02):

WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 02): - Quality Management
(2006; 19 pages)

Table des matières

Quality Management

Objectives

To understand key issues in quality assurance/good manufacturing practices/quality control.
To understand specific requirements on quality management and quality assurance including:

- Organization

- Procedures, processes and resources.
To develop actions to resolve your current problems.

In this session we want you to achieve the following:

1. To understand the key issues in relation to quality assurance and quality control.

2. To understand the special needs in terms of organization, procedures, processes and resources, including staffing.

3. In your group session, to look at the special situations and problems that you face in these areas in your country, and to develop practical solutions.

This area of work is potentially difficult because of the need to understand clearly the difference between quality management, quality assurance (QA) and quality control (QC).

We will be looking at the issues that can arise in implementation, and at your own experiences.

We will consider questions such as what to do about the owner of a factory who insists on appointing his/her son or daughter, who is not qualified, into a position of responsibility, and what to do about a factory that insists that it can manufacture penicillin products without cross-contamination risk, in the same equipment and premises used for manufacture of other types of product.