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dag56 replied to the topic Best timing for validation and verification in the forum Introduction to Project Management 8 years, 4 months ago
I agree with the two above posts which state that he process and design verifications are done towards the end of the specified project.A successful validation program depends upon information and knowledge from product and process development. I would like to further emphasize that process validation encompasses a series of activities taking place over the lifecycle of the product and process. This can be broken up into 3 distinct ‘stages’:
Stage 1 – Process Design: The commercial manufacturing process is outlined within this stage based on knowledge gained through research and development along with the process of scaling up production of the product.
Stage 2 – Process Qualification: Encompassed within this stage, the process design is investigated to determine if the proposed process is capable of reproducible commercial manufacturing within the given tolerances.
Stage 3 – Continued Process Verification: Ongoing assurance is done during the routine production of the product that the process remains in a state of control. This to ensure the product remains within tolerances while being routinely manufactured and to observe any early warning signs.