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Process validation is establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined.

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Guidance documents do not establish legally enforceable rights or responsibilities They do not legally bind the public or FDA 2 You may choose to use an approach other than the one set forth in a guidance document However your alternative approach must comply with the relevant statutes and regulations.

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Department of Commerce Guidance Documents A guidance document is an agency statement of general applicability and future effect other than a regulatory action that sets forth a policy on a statutory regulatory or technical issue or an interpretation of a statute or regulation.


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