Cleaning Validation - Microbial Monitoring.pptVIP

CLEANING VALIDATION Microbial Monitoring Anthony M. Cundell Ph. D. Associate Director, QA Microbiological Development Statistics Wyeth-Ayerst Pharmaceuticals Pearl River, New York CLEANING VALIDATION What are the the current Good Manufacturing Practices requirements for cleaning validation? CLEANING VALIDATION 21 CFR 211.67 Equipment cleaning and maintenance a) Equipment and utensils shall be cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. CLEANING VALIDATION 21 CFR 211.