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). If a company proposes to make use of a thief sampling approach, the reliability of the method need to be evaluated as Section of analytical solutions growth. You will find a method of self-inspection and/or excellent audit that routinely appraises the effectiveness and applicability of the standard assurance method. Microbial contaminatio
Non-practical particle rely check shall be carried out as per The present version of SOP furnished by an accepted external agency.Correct documentation of commissioning is A necessary Section of the productive validation of pharmaceutical water system. Commissioning involves the startup of your water system with documenting the general performance
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