- Mots-clés > GMP inspectors and manufacturers
- Mots-clés > good engineering practices (GEP)
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > inspection of pharmaceutical products - standard operating procedures
- Mots-clés > quality assurance
- Mots-clés > Standards Operating Procedures (SOP)
- Mots-clés > validation - manufacturing process
- Mots-clés > validation and qualification
- Mots-clés > validation, water, air handling systems
- Mots-clés > WHO expert committee
(2006; 72 pages)
Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.
These guidelines aim to give guidance to inspectors of pharmaceutical manufacturing facilities and manufacturers of pharmaceutical products on the requirements for validation. The main part covers the general principles of validation and qualification. In addition to the main part, appendices on validation and qualification (e.g. cleaning, computer and computerized systems, equipment, utilities and systems, and analytical methods) are included...