Cleaning Process Development and Validation.ppt

Cleaning Process Development and Validation June 16, 2006 Brian Kim VP of Quality Tanox, Inc. Regulatory/Compliance Overview Applicable regulations and requirements 21 CFR 211.65 a) Equipment …. surfaces which contact components, in-process materials, or drug products shall not be reactive, additive or absorptive….. 21 CFR 211.67 Equipment and utensil …. cleaned, maintained, and sanitized at appropriate intervals to prevent …or contamination that would alter the safety, identity, strength, quality, or purity …… Regulatory/Compliance Overview 21 CFR 211.182 Written cleaning Procedure Cleaning and use log Cholestyramine Resin USP recall due to the low level contamination with intermediates and degradants after reuse of recovered solvents from pesticide production – increased FDA awareness. Regulatory/Compliance Overview Guidance Guide to Inspection for Validation of Cleaning Processes. FDA, 1993 ICH Q7A, GMP for Pharmaceutical Active Ingredients Regulatory/Compliance Overview FDA 21 Century Risk-Based Quality System Initiative Define critical product attributes and control of critical processes (Process Capacity) to ensure: SAFETY, PURITY, EFFICACY, QUALITY Design “Quality” into processes Science-based risk management Real time QA Cleaning Validation Overview Objectives Assurance of product purity, safety, efficacy and quality Prevention of product cross contamination by byproduct, residual product, microbial residue and residual detergent When cleaning validation is required Introduction of new equipment/product Manufacturing/cleaning process changes Raw material/cleaning agent changes Cleaning Validation Overview Good system design Comprehensive Master Validation Program Effective cleaning process development Adequate analytical technique Justifiable acceptance criteria – product specific (How Clean is Clean?) Continuous data monitoring and evaluation Acceptance criteria adjustment as necessary Cleaning Validation Overview Routine review of