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(a) Composed methods shall be founded and followed prescribing a program for reprocessing batches that don't conform to criteria or specifications and the methods to generally be taken to insure which the reprocessed batches will conform with all founded standards, requirements, and characteristics.

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(a) There shall become a created tests plan meant to assess The steadiness qualities of drug products. The final results of such balance screening shall be used in deciding acceptable storage situations and expiration dates. The composed plan shall be adopted and shall include things like:(1

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