21 CFR 211.100 - Written procedures; deviations.
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(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.