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Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Do these minimums seem reasonable?

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Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification. Overall sanitation of the plant shall be under the supervision of one or black girl and white boy dating competent individuals assigned responsibility for this function.

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Do policies governing record retention specifically apply to cloud vendors? If electronic records are illegible, inaccessible, or corrupted, manufacturers are still subject to those requirements. Insofar as necessary, equipment shall be taken apart for thorough cleaning.

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All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate the contamination.

Coverage[ edit ] Practically speaking, Part 11 applies to drug makersmedical device manufacturers, biotech companies, biologics developers, CROsand other FDA-regulated industries, with some specific exceptions.

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Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following:

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