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

Quality Assurance

Manufacturer is responsible for the quality of the product

- Fit for intended use

- Comply with marketing authorization

- Safety, efficacy and quality
Senior management and commitment of all staff

The manufacturer is responsible for the quality of the product and has to ensure that it is fit for the intended use, complies with marketing authorization and the requirements for safety, efficacy and quality

It requires involvement of senior management and commitment of all staff