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Computerized systems utilized for the manufacture of medicinal products should also be validated Based on the requirements of Annex eleven. The relevant concepts and steerage offered in ICH Q8, Q9, Q10 and Q11 also needs to be taken under consideration.hii can anyone counsel how we can outsource purifies water and what document we have to get ready
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Validation Protocol implies the protocol that has been or might be mutually arranged from the Events hereto, which describes the checks and acceptance conditions utilized to demonstrate that a process yields a given Products which continuously meets the Specs.Right documentation of commissioning is A vital Element of the effective validation of ph
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