Abstract
The qualification Stage 2 encompasses Stage 2A and Stage 2B. Stage 2A ensures that the equipment, utilities, facility, and system designs are adequately qualified. Stage 2B further ensures the qualification of process performance. Process performance qualification (PPQ) or Stage 2B confirms that the manufacturing process as designed is capable of reproducible commercial manufacturing. Heightened sampling and testing is recommended during Stage 2B while simulating standard commercial manufacturing conditions. PPQ activities are performed in line with lifecycle approach by incorporating quality risk management and statistically based assessments. Completion of Stage 2B studies is a major milestone for product commercialization. The final PPQ report hence is required to be thoroughly reviewed and approved by the responsible departments to ensure the adequacy of processes prior to moving to commercial manufacturing. As an outcome, the PPQ report may suggest change control requirements to further enhance the control strategy for the product per lifecycle requirements.
Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
