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Case File #02
Batch Release Decision Record
The Batch Was Released. The Decision Basis Was Not Preserved.
21 CFR 211.22(a) · 21 CFR 211.188 · 21 CFR 211.192
| Decision | Batch release of Lot 2023-0847, Lisinopril Tablets 10 mg |
|---|---|
| Inspection challenge | Investigator requested the evidence reviewed, the treatment of Deviation DR-2023-0088, the risk judgment, and the accountable decision owner |
| Decision-record gap | No contemporaneous record explaining why the release decision was made |
| Reconstruction Tax | Retrospective review of 94 lots across 18 months, CAPA, procedure and template revision, and QA retraining |
01 / Inspection Trigger
What the Investigator Asked
During inspection of batch release records for Lot 2023-0847, Lisinopril Tablets 10 mg, the investigator reviewed the batch record package and found a QA release signature on the certificate of analysis. The firm had a batch record, passing test results, a closed deviation, and that signature — but no contemporaneous record responsive to what the investigator asked next.
"Who reviewed this batch before release, how was Deviation DR-2023-0088 evaluated in the context of the release decision, what risk judgment supported release, and who accepted responsibility for authorizing distribution of this lot?"
A QA signature on a certificate of analysis confirms the document was checked. It does not, on its own, establish that a controlled, accountable decision event occurred — which evidence was reviewed, how the deviation was weighed, or who accepted responsibility for the outcome.
The investigator was not asking whether GMP records existed. The investigator was asking whether the firm could explain why release was authorized.
02 / Decision-Record Gap
What Existed. What Was Missing.
What existed: batch documentation, passing test results, a closed deviation, and a QA signature.
What was missing: one contemporaneous record explaining what was reviewed, how the deviation was evaluated, what risk judgment supported release, and who authorized distribution.
The Complete Case File maps the full decision-record gap: the evidence that existed, the decision elements that were absent, and why the underlying GMP records did not answer the investigator's questions.
03 / Reconstruction Tax
The Cost of Reconstructing a Decision
The missing decision basis triggered retrospective review across 94 lots released over 18 months, plus CAPA, procedure revision, template revision, retraining, and enhanced quality review.
The organization did not need to recreate manufacturing activity. It needed to recreate the reasoning, risk judgment, and authorization behind decisions already made.
The Complete Case File traces how a single missing decision record became a system-level reconstruction burden, including the specific remediation work, quality oversight implications, and management cost drivers.
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