Transcription of A guide to planning your Cleaning Validation Study
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A guide to planning your Cleaning Validation Study
A guide to planning your Cleaning Validation StudyClearance ..1 Why undertake a Cleaning Validation Study ?..1 Process Validation for removal and inactivation of bacteria, fungi, and criteria for microorganisms ..2 Study protocol ..4 Study protocol including microbial Validation ..7 Cleaning agents ..8 Calculation methods: logarithmic reduction Validation Study handling and record maintenance ..9 Delivering the Study guide to planning your Cleaning Validation Study undertake a Cleaning Validation Study ? Cleaning Validation studies are performed to establish docu-mented evidence which demonstrates with a high degree of assurance that an equipment-specific Cleaning process will consistently yield results meeting specifications and quality attributes. GMP regulations explicitly state that manufacturers of finished pharmaceuticals must properly clean their facilities and equipment to ensure product safety: 21 CFR (a) Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to pre-vent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug prod-uct beyond the official or other established requirements.
uct goes through phase III clinical trials. Common situations that lead manufacturers to conduct cleaning validation studies ... A guide to planning your Cleaning Validation Study 5 www.bioreliance.com Study protocol including microbial spiking Proper study design must take into account multiple vari-
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