FDA Inspection Decision Scenario
Who Authorized the Retest Period Extension?
What FDA investigators are actually asking
FDA Investigator Question
"Who made the determination that the stability data supported extending the retest period, and what was the regulatory basis?"
Inspector's Line of Inquiry
When investigators ask this question, they typically follow with:
- Who reviewed the stability trending data before the extension was authorized?
- What ICH Q1A extrapolation criteria were applied to the extension determination?
- What degradation trends were evaluated before the conclusion was made?
- What data would have prevented the extension from being granted?
- When was the retest extension formally authorized, and who is named as the decision owner?
Can your team answer this question in under five minutes? The Authorization Assessment identifies where your decision trail breaks before an investigator does.
Find Your Gaps →The authorization gap this scenario reveals
The investigator is reviewing API or excipient records. A retest period extension was granted. The investigator asks who made the authorization decision.
Authorization Gap
The retest extension record documents stability data that supported the decision. It does not document who evaluated that data and made the formal authorization that the extension was scientifically and regulatorily justified. This is the authorization gap: the decision was made, but it was never documented as an authorization event — with a named decision owner, the evidence reviewed, the regulatory standard applied, and a timestamped record of when the authorization occurred.
Why does this gap exist across so many compliance programs? The Decision Authorization Model explains the structural difference between what documentation systems produce and what inspectors evaluate.
Understand the Model →What evidence the investigator expects
- Named individual accountable for the retest extension authorization
- Stability data reviewed before the extension was granted
- ICH guideline applied to the retest period determination
- Authorization timestamp for the extension decision
- Rationale for why the stability trend supported the extended retest period
Organizations operating with authorization infrastructure produce this record at the moment the decision is made.
See how authorization capability scales across organizations →These gaps are not documentation failures. They are authorization failures. The Authorization Assessment maps exactly where your decision trail is missing these elements.
Start the Assessment →Authorization Assessment
Which of your decisions
have an authorization gap?
The Authorization Assessment identifies where your compliance decisions are undocumented as authorization events — the exact gap inspectors expose in scenarios like this one.
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Inspection Case Files document the authorization gap in detail — showing exactly what a Decision Defense Record resolves and what inspectors expect to see.
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