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Fda certificate of analysis requirements

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(1) Written procedures for fulfilling the requirements of this subpart B; and (2) Documentation of training, including the date of the training, the type of training, and the person (s) trained.

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The Certificate of Analysis is a legally binding document that is issued by a certification authority regarding a product. The document attests that the product has undergone extensive testing in a certified lab. The document will include how the product follows the specifications and regulations provided by both the customer and the manufacturer as well as any governing entities.

A Certificate of Analysis is a document from a supplier that states the identity, purity or microbiological state of a product. It shows that the supplier completed the required testing and that the results meet the product specifications. This allows customers to have written proof of whether the product is safe and/or meets specifications.

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