Define cleaning responsibilities
Written validation procedures should address responsibilities and acceptance decisions.
CV-REQ-000008
Validation of Cleaning Processes§ General requirements
SOURCE DOCUMENT / FDA
Validation of Cleaning Processes
Inspection guide · July 1993
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 Jul 1993
References in this document
Prepare a study protocol
Prepare protocols addressing sampling and analytical method sensitivity.
CV-REQ-000009
Validation of Cleaning Processes§ General requirements
Understand swab compatibility
Sampling materials and extraction solvents can influence analytical results.
CV-REQ-000010
Validation of Cleaning Processes§ Direct surface sampling
Understand the rinse result
Rinse testing must meaningfully represent residues on equipment surfaces.
CV-REQ-000011
Validation of Cleaning Processes§ Rinse samples
Control time before cleaning
Residue drying can affect the effectiveness of a cleaning procedure.
CV-REQ-000012
Validation of Cleaning Processes§ Evaluation of cleaning validation
Document the validation conclusion
A management-approved report should establish whether cleaning is validated.
CV-REQ-000013
Validation of Cleaning Processes§ General requirements