CLEANING VALIDATION CURRENT APPROACH AND PRINCIPLES AND PROCESS VALIDATION LIFECYCLE APPROACH

This two (2) days course will cover current thinking and approach to cleaning validation and process validation. Current guidelines will be referenced, with emphasis on statistical applications and lifecycle approach to both validation processes. References: PIC/S PE 009-14 (Annexes), ISPE Guides: Practical Implementation of the Lifecycle approach to Process Validation, Technology Transfer, Product realization by QbD, Process Performance and Product Quality Monitoring system, Determination of Number of PPQ batches Using Statistical Tool, Risk-Based Manufacture of Pharmaceutical Products. PDA Technical Reports: No. 60 Process Validation: A Lifecycle approach, PDA Technical 60.2 Process Validation: A Lifecycle approach, No.29: Points to Consider for Cleaning Validation. EMA Guides: Setting health-based exposure limits (HBELs) for use in risk identification in the manufacture of different medicinal products in shared facilities.

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