USFDA Guidance on Cleaning Validation
Is there a USFDA regulatory guidance on Cleaning Validation
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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Is there a USFDA regulatory guidance on Cleaning Validation
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There is a GUIDE TO INSPECTIONS : VALIDATION OF CLEANING PROCESSES by USFDA. This details the expectation of USFDA in a Cleaning Validation program. However, the APIC (Active Pharmaceutical Ingredients Committee): Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient Plants is the guidance that gives a detailed stepwise approach for the implementation of a Cleaning Validation program.