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What is the process validation?
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Answer / navinpatel
As per USFDA,Process validation is defined as the collection
and evaluation of data, from the process design stage
through commercial production, which establishes scientific
evidence that a process is capable of consistently
delivering quality product. Process validation involves a
series of activities taking place over the lifecycle of the
product and process.
The guidance documents describes process validation
activities in three stages:
Stage 1 – Process Design
Stage 2 – Process Qualification
Stage 3 – Continued Process Verification
For more information please refer: Guidance for Industry:
Process Validation: General Principles and Practices,
January 2011
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