Transcription of Systems-Based Inspections Describe ... - Cleaning Validation
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Systems-Based Inspections Describe ... - Cleaning Validation
Cleaning Validation /LeBlanc/FDA DG 230 July 20, 201711 Systems-Based Inspectionsfor Cleaning ValidationFDA DG 230 July 20, 2017 New Orleans, LADestin A. LeBlancCleaning Validation Describe Cleaning processes andapproaches Identify various techniques utilizedto measure the effectiveness ofcleaning processes Identify documents associated withcleaning Validation processes Identify significant issues and typicalproblems with Cleaning validation3 Cleaning Definition: The process ofremoving potential contaminantsfrom process equipment such thatthe equipment can be safely usedfor subsequent productmanufacture Focus for this presentation isprocess equipment, not cleanroomcleaning4 Critical Cleaning ? Criticalcleaning must be validated Cleaning between products Focus on product contact surfaces Significantindirect product contactsurfaces Applies to drug products and APIs Dedicatedequipment Documented evidence of effectiveness Also address Cleaning agent andbioburden5 Non-critical Cleaning ?
Cleaning Validation/LeBlanc/FDADG 230 July 20, 2017 3 13 Differences PV vs. CV (3) Processes For production process, each manufacturing process is more or less unique For cleaning process, firms prefer to use one cleaning process for all
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