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Acceptance criteria for residues and the selection of cleaning processes and cleansing agents needs to be described and justified.Releasing or rejecting all APIs. Releasing or rejecting intermediates to be used exterior the control of the manufacturing companyIn which the caliber of the API could be afflicted by microbial contamination, manipulatio
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states "solutions validation is the entire process of demonstrating that analytical techniques are well suited for their supposed use" (five). There also are a lot of documents defining validation inside the context of processes. From FDA's Guideline on Common Concepts of System Validation:External Agency shall supply specialized support for prepar