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All copies of primary documentation needs to be formally confirmed as a real copy and has to be distinguishable to the initial, also using a duplicate doesn't mean that the original document is usually discarded, the original have to be preserved.Create audit trails that document changes to data and make sure information cannot be altered without d

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(one) Sample sizing and test intervals determined by statistical requirements for every attribute examined to assure valid estimates of steadiness;Records of manufacture (together with distribution) that help the whole record of the batch being traced must be retained inside a comprehensible and accessible form.19. For the nonsterile compendial dru

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