- Palabras clave > GMP inspectors and manufacturers
- Palabras clave > good engineering practices (GEP)
- Palabras clave > Good Manufacturing Practices (GMP)
- Palabras clave > inspection of pharmaceutical products - standard operating procedures
- Palabras clave > quality assurance
- Palabras clave > Standards Operating Procedures (SOP)
- Palabras clave > validation - manufacturing process
- Palabras clave > validation and qualification
- Palabras clave > validation, water, air handling systems
- Palabras clave > 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...