质量以及药品生产和质量管理课件学习资料.pptVIP

It is important that you read the guidelines and familiarize yourself with the terms and definitions in the Glossary part. You should know what the terms mean, and also the differences between different concepts including calibration and qualification. 4. Relationship between validation and qualification Validation and qualification are essentially components of the same concept. The term qualification is normally used for equipment, utilities and systems, and validation for processes. In this sense, qualification is part of validation. 5. Validation 5.1 Approaches to validation 5.1.1 There a