Stage 3A and Stage 3B: Continued Process Verification
Monitoring adds assurance that during routine commercial production of drug products, the process remains in a state of control. Through life cycle Stage 1, critical material attributes and CQAs are established; critical process parameters (CPPs) and process control strategies are defined. CPPs and CQAs are verified in Stage 2. As the product moves to Stage 3, the body of data grows significantly. At Stage 3A and 3B, CPV data continues to be generated until the product is discontinued. As data is available in real time, it allows immediate action for continuous improvement upon signal detection.
KeywordsContinued process verification Ongoing process verification Continuous improvement Stage 3 Variability Statistical assessment
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