This video is about Process Validation | PV and its Life cycle approach
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Process Validation:
Definition as per FDA
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics
Definition as per WHO
The collection and evaluation of data, throughout the product life-cycle, which provides documented scientific evidence that a process is capable of consistently delivering quality products.
Definition as per EMA
The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
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