Define cleaning responsibilities
Written validation procedures should address responsibilities and acceptance decisions.
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AUTHORITY / United States
FDA
U.S. Food and Drug Administration
Source documents
Inspection guide · July 1993
Validation of Cleaning Processes
Guidance · August 2001
Q7A: Good Manufacturing Practice for APIs
Connected references
Prepare a study protocol
Prepare protocols addressing sampling and analytical method sensitivity.
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Understand swab compatibility
Sampling materials and extraction solvents can influence analytical results.
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Understand the rinse result
Rinse testing must meaningfully represent residues on equipment surfaces.
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Control time before cleaning
Residue drying can affect the effectiveness of a cleaning procedure.
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Document the validation conclusion
A management-approved report should establish whether cleaning is validated.
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Reflect actual equipment use
Cleaning validation should reflect how equipment is actually used.
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Describe the cleaning study
Protocols should describe equipment, procedures, criteria and sample collection.
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Select suitable sampling methods
Sampling should address soluble and insoluble residues appropriately.
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Establish method capability
Analytical sensitivity and attainable recovery should support residue evaluation.
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Monitor cleaning after validation
Monitor validated cleaning procedures at appropriate intervals during production.
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Review the validated state
Periodically evaluate whether systems remain in a valid state.
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