CLEANING VALIDATION WITH RISK ASSESSMENT
APIC (A Sector Group of CEFIC) Guide “Cleaning Validation in Active Pharmaceutical Ingredient Manufacturing Plants (1999)” & Companion Document “Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants (2000)” Defined Cleaning Validation (CV) for APIs as “The Process of Providing
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GMP Requirements
www.usp-pqm.orgQuality Management Requirements for QA Systems 1. Ensure products are developed correctly 2. Identify managerial responsibilities 3. Provide SOPs for production and control 4. Organize supply and use of correct starting materials 5. Define controls for all stages of manufacture and packaging. 6. Ensure finished product correctly processed and
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