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As a result, it is of paramount importance to obviously determine from the VMP what has to be validated, the extent of validation needed for every facility / procedure / products / analytical process, the actions to become taken in case of a big transform (e.g. the replacement of the production / high-quality control instrument with a different 1)
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The manufacturer will review the design. In the event the design is ok, from the construction viewpoint, the maker will put remarks on it.Crucial top quality characteristics and critical system parameters are important inputs into consumer specifications technical specs, and the quality threat administration commissioning and qualification system