Evidence
Batch record, testing, corrections, deviations, excursions, and other information relied upon.
Batch Record Review
Can QA show the basis for release—not only the completed batch record?
A batch record can be complete and the release signature can be present while the reasoning behind disposition remains scattered across deviations, testing, corrections, exception reviews, and individual judgment.
The release distinction
Release is a decision. The batch record is evidence for that decision.
Batch record review establishes whether required manufacturing and control information is present and whether exceptions have been addressed. Release authorization goes one step further: it connects the available evidence to the Quality judgment that the batch is acceptable for disposition.
When that connection is not preserved, a later reviewer may see the records and the signature but still have to reconstruct why QA concluded release was justified.
The release record
What should remain visible after release?
Judgment
How QA evaluated the evidence and determined the batch met the applicable release standard.
Risk
Exceptions, uncertainty, controls, conditions, and residual risk accepted at disposition.
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Authorization
Who authorized release and why that person or role held release authority.
What QA must be able to explain
A strong review does not stop at completeness.
Batch record review
Were entries complete, attributable, legible, contemporaneous, and internally consistent?
Batch record corrections
Were corrections controlled, explainable, and evaluated for any impact on product or record reliability?
Deviation and exception review
Did open or closed deviations, excursions, or atypical events change the release judgment?
Release authorization
Can another qualified reviewer understand why the available evidence supported release?
Choose the proof that matches the problem
Inspect an example before applying the approach to an actual release decision.
The completed Case File shows what a preserved batch-release decision looks like. The Defense Pack is a working product for creating a structured authorization record around an actual release decision. The IRR is for preserving the complete basis behind a consequential GMP decision when the exposure is broader than release alone.
Related authority pages