Life Cycle Approach to Process Validation- Stage 3 Implementation
Complimentary
Learning Level: Intermediate
Time: 1100 - 1200 EST
Session Length: 1 hour
Process validation is a fundamental requirement in pharmaceutical manufacturing, ensuring that drugs meet regulatory and quality standards. A lifecycle-based approach, incorporating risk assessments and statistical analysis, helps manufacturers maintain product consistency while minimizing variability. Through systematic studies and data analysis, quality can be built from stage 1 through decommissioning. Trending data and analyzing the trend during stage 3, Continued Process Verification (CPV) of the life cycle approach to monitor performance, is an expectation from the regulatory agencies. How and when, and what are the challenges the industry needs to tackle.
A case study addressing the implementation of the stage 3 monitoring and control strategy is discussed in this presentation. The inherent process variability and analytical variability are to be considered when control limits are set for routine process manufacturing. The application of various (Control charts, Capability Analysis, Hypothesis testing, etc.) Statistical Process Control (SPC) is demonstrated to monitor process variability over time. These tools help detect variations, identify trends, and ensure the process remains within established limits.
Learning Objectives
- Explain the life cycle approach and expectations of regulatory agencies for Process Validation.
- Implementation of the Life Cycle Approach and application of statistical analysis at each stage of the Life Cycle Approach.
- Walk through a case study for the implementation of Stage 3 Continued Process Verification and control strategies to maintain the capability of the process.
