Deviations from approved specifications of calibration on important instruments needs to be investigated to ascertain if these could have experienced an impact on the standard of the intermediate(s) or API(s) manufactured using this gear since the past productive calibration.There need to be documented methods developed to ensure that correct packa

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Validation Protocol: Validation protocol is really a document that signifies the company’s method of validation of analytical procedures. It assures dependable and efficient execution of validation assignments and also responses auditor throughout audits.Adhering to knowledge integrity principles, which include knowledge traceability, controlled