About this document
EU GMP Annex 15: Process Validation Guide by BlueSaga is a document available to read on EtoBox.
The document discusses different approaches to validation of manufacturing processes, including prospective validation, concurrent validation, and retrospective validation. Prospective validation is preferred and must be done prior to product release whenever possible. Concurrent validation may only be used in exceptional circumstances with strong justification and approval. Retrospective validation is no longer considered an acceptable approach. The document also discusses process validation strategies suc
- Author
- BlueSaga
- Language
- EN