Batch Record Review Before Release
Explain how batch record review protects release decisions by testing completeness, deviations, and quality unit authority.
Batch review is a release decision, not a page count. The quality unit reviews the record to decide whether the lot was made under control. The strongest review follows the story of the batch: approved instructions, trained people, qualified equipment, controlled materials, critical process steps, in-process checks, deviations, calculations, reconciliation, and final disposition. The useful question is not "Is there a signature?" It is "Does this evidence support the quality decision without relying on memory?" A signature on an incomplete page is weak evidence. A passing final test does not erase an uninvestigated process excursion. A correction without reason and…
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