Case File #01 — Batch Record Review Authorization

Inspection Trigger

Investigator reviewed the batch record for Lot 2024-0081, noting QA initials on each page and a signed cover page. The investigator then asked who authorized the determination that the review was complete and the record was acceptable.

Decision Failure

The firm could not produce documentation identifying who authorized the batch record review determination, what discrepancies were evaluated before that decision, or what regulatory standard governed the review authorization.

Regulatory Exposure

21 CFR 211.192 requires that batch production and control records be reviewed and approved by the quality control unit. The authorization decision — who reviewed what evidence and on what basis — must be formally documented at the time of release.

Decision Defense Record

A batch record review authorization documenting the named decision owner, discrepancies evaluated, release criteria applied, and timestamped authorization would have produced an inspection-defensible record and answered the investigator's question immediately.

Section 01

What the Investigator Asked

483 Observation — Batch Record Authorization Failure

During inspection of the manufacturing facility, the investigator reviewed the batch record for Lot 2024-0081, a commercial batch of Metformin HCl Tablets 500 mg. The batch record contained QA initials on each page, a signed cover sheet, and cross-references to two open deviation records. The investigator requested documentation identifying the individual who authorized the determination that the batch record review was complete and the record was acceptable for disposition — and what evaluation of the deviation records preceded that authorization. No authorization record responsive to either question was produced. The investigator requested all batch records released in the preceding 18 months for review.

Inspector's Question

"Who authorized the completion of this batch record review — and what discrepancies were evaluated before that determination was made?"

A signed batch record cover page confirms that someone reviewed the record. It does not document an authorization decision. The investigator's question targets something different — the formal determination that the review was complete, the discrepancies were evaluated and found acceptable, and the record was ready for disposition.

A QA signature on a batch record confirms presence. It does not document the authorization logic — what was evaluated, what standard was applied, and who held the authority to make the release determination. That distinction is what generates the observation.

Section 02

Evidence Present vs. Authorization Missing

What Existed	What Was Missing
✓ Batch record with QA initials on each page	→ Named individual who authorized the determination that the review was complete
✓ Signed batch record cover sheet	→ Formal record of what discrepancies were evaluated before authorization
✓ Two open deviation records cross-referenced	→ Documentation of how deviations were assessed against release criteria
✓ QC analytical results within specification	→ Regulatory standard applied to the authorization decision
✓ Certificate of analysis issued	→ Timestamp confirming authorization preceded disposition, not post-hoc
✓ Batch disposition recorded in QMS	→ Authorization statement identifying who accepted responsibility for the release determination

A completed batch record confirms the manufacturing process was documented. It does not document the authorization decision. The authorization record identifies who evaluated which evidence against which release criteria and formally accepted responsibility for the disposition determination — at the moment it was made.

Section 03The Operational Cost — Retrospective review authorization required for all batches released in the preceding 18 months. Batch record review SOP revised to require formal authorization documentation. Discrepancy evaluation standard defined and incorporated into the review authorization procedure.

Section 04DDR Reconstruction — The complete Decision Defense Record for this batch record review authorization: named decision owner, discrepancies evaluated, release criteria applied, deviation assessment, regulatory standard anchored, and timestamped authorization statement.

Section 05Authorization Model — The five required elements for batch record review authorization, including the discrepancy evaluation standard and the release criteria framework FDA expects to see documented at the time of authorization.

Section 06Preventive Control — Mandatory authorization record at batch record review completion, structured discrepancy evaluation log, and release gate requiring formal decision documentation before disposition status is available in the QMS.

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Four Sections Remaining

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Batch Record Review — The record was reviewed. But who authorized that determination?

What the Investigator Asked

Evidence Present vs. Authorization Missing

Does your organization have authorization records that hold up under this level of scrutiny?