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Timestamp: 2018-09-22 02:11:03
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Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 by Food and Drug Administration - PROFITEROLTARIFI.NET Library
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Additional resources for Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs
Such procedures shall include validation of any sterilization process. 115 Reprocessing. (a) Written procedures shall be established and followed prescribing a system for reprocessing 39 batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics. (b) Reprocessing shall not be performed without the review and approval of the quality control unit. 122 Materials examination and usage criteria.
Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. 52 (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products.
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