Reflect actual equipment use
Cleaning validation should reflect how equipment is actually used.
CV-REQ-000014
Q7A: Good Manufacturing Practice for APIs§ 12.7 — equipment usage
SOURCE DOCUMENT / FDA
Q7A: Good Manufacturing Practice for APIs
Guidance · August 2001
This page describes the cited edition. Source status and the summary of each requirement are verified against the original document. Full third-party documents are not reproduced here.
Published: 1 Aug 2001
References in this document
Describe the cleaning study
Protocols should describe equipment, procedures, criteria and sample collection.
CV-REQ-000015
Q7A: Good Manufacturing Practice for APIs§ 12.7 — protocol
Select suitable sampling methods
Sampling should address soluble and insoluble residues appropriately.
CV-REQ-000016
Q7A: Good Manufacturing Practice for APIs§ 12.7 — sampling
Establish method capability
Analytical sensitivity and attainable recovery should support residue evaluation.
CV-REQ-000017
Q7A: Good Manufacturing Practice for APIs§ 12.7 — analytical methods
Monitor cleaning after validation
Monitor validated cleaning procedures at appropriate intervals during production.
CV-REQ-000018
Q7A: Good Manufacturing Practice for APIs§ 12.7 — ongoing monitoring
Review the validated state
Periodically evaluate whether systems remain in a valid state.
CV-REQ-000019
Q7A: Good Manufacturing Practice for APIs§ 12.6