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CLEANING VALIDATION WITH RISK ASSESSMENT

2016. ALL RIGHTS RESERVED. CLEANING VALIDATION with RISK ASSESSMENT Bangkok, Thailand July 26 2017 Jairaj (Jai) Mehta, Consultant, Promoting the Quality of Medicines CLEANING VALIDATION with Risk ASSESSMENT Presentation Outline: Regulatory History and Guidelines Evolution of CLEANING VALIDATION and Risk ASSESSMENT US FDA Guide to Inspection of VALIDATION of CLEANING processes (1993) US FDA Draft Guidance for Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (1998) APIC Guide CLEANING VALIDATION in Active Pharmaceutical Ingredient Manufacturing Plants (1999) & Companion Document Guidance on Aspects of CLEANING VALIDATION in Active Pharmaceutical Ingredient Plants (2000)

US FDA Guide to Inspection of Validation of Cleaning Processes (1993) ... RISK MANAGEMENT METHODOLOGY - Industry and Regulators Can Assess and Manage Risk Using Published Risk Management Tools and/or Internal Procedures (E.G., Standard Operating Procedures). A List Of Some Of These Tools Provided in the ICH

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