Part 01 · The Question→Part 02 · The Record→Part 03 · The File
← Part 01
Inspection Case File · CF05 · Part 02 of 03

The five fields the FDA investigator expects to find — and the one most files don't have.

A change control approval with a signature is not the same as a change control approval with a documented decision. The investigator can tell the difference in thirty seconds.

See the Complete File → Free to read. Buy decision is on the next page.
What separates a decision from a signature

A signature on a change control approval proves that a person signed. It does not prove what they decided.

Under inspection, a signature is evidence of an event. It is not evidence of a decision. The investigator does not doubt the signature. She doubts that anything was decided.

An authorization record is structured to be evidence of a decision. It names the person, the moment, the evidence reviewed, the alternatives evaluated, and the basis on which the conclusion was reached. The investigator does not have to ask the QA Director what she was thinking. The record answers.

Investigator
"Who authorized the risk determination for this change, on what evidence, and how was the conclusion that the change did not require revalidation justified at the moment of decision?"
This is the question that requires Field 03 of the authorization record to exist.
The Authorization Record · Required Structure

Five fields. Missing any one is the gap a 483 cites.

Every authorization record for a change control risk categorization must contain the following five fields. The third field is the one that is almost always missing.

  1. 01
    The categorization being authorized
    Stated as a decision, not a description. Not "low risk." Specifically: the conclusion that the substitution of microcrystalline cellulose supplier from Vendor A to Vendor B constitutes a like-for-like change, on the basis of documented comparison of particle size distribution, density, moisture content, and tablet performance attributes.
  2. 02
    The comparison evidence reviewed at authorization
    Every property formally compared between previous and new materials. Specifications, certificates of analysis, performance test results, historical lot data. Each comparison documented, each gap identified.
  3. 03
    Higher-risk categorizations evaluated and rejectedMost Often Missing
    The candidate categorizations considered before low-risk was concluded. Not "we considered higher risk." The actual alternatives — moderate risk requiring bridging studies, high risk requiring full requalification — and the documented basis on which each was rejected. This is the section a 483 cites when it is missing.
  4. 04
    The risk evaluation applied
    What was at stake if the categorization was wrong. Patient impact, batch failure risk, regulatory filing implications.
  5. 05
    The named decision owner and timestamp
    The individual whose authority basis is documented. Not the CCB chair signature. The person who reviewed the comparison evidence, evaluated the higher-risk alternatives, applied the risk standard, and authorized the categorization.
Why Field 03 matters most

A change control file almost never contains a documented evaluation of the higher-risk categorizations that were rejected. The investigator opens to it first.

Most change control determinations conclude with a single risk categorization. They rarely document the higher-risk categorizations that were evaluated and rejected to arrive there. The investigator knows this. It is the field she opens to first.

If field 03 is empty, every other field is suspect. The evidence in field 02 may have been reviewed, but no alternative interpretations are on record. The conclusion in field 01 may be correct, but the reasoning is unreconstructable. The signature in field 05 attests to the conclusion, not to the analysis that produced it.

An authorization record without a documented evaluation of the alternatives is not an authorization record. It is a signature on a conclusion.

Why this matters now

The five-field structure is the same whether the inspection is this quarter or next year. The difference is whether you build the record now — when you have time, evidence, and the original decision-maker available — or under inspection pressure when none of those are guaranteed.

Reference Example

AR-CC-001 — Metoprolol Tartrate Tablets 50 mg — Change Control CC-2024-0156

The same scenario from Part 01, with the authorization record that should have existed in the file. Excerpt from the complete reference authorization record.

Authorization Record · AR-CC-001 · Excerpt
Change Control Risk Determination — CC-2024-0156
Decision Authorized
The conclusion that the supplier substitution from Vendor A to Vendor B for microcrystalline cellulose is a like-for-like change of low risk, on the basis of documented comparison of particle size distribution, bulk density, tapped density, moisture content, and historical lot performance data.
Authorizing Individual
Dr. Patricia Chen, VP Quality Systems
Authority Basis
CC-AUTH-003 §4.1 — designated authority for change control risk categorization on excipient supplier changes
Evidence Reviewed
CC-2024-0156 · COA Vendor A historical · COA Vendor B qualification · Particle size comparison PSC-2024-MCC-0156 · Density comparison · Moisture data · Tablet performance correlation
Alternatives Eliminated
Moderate risk requiring bridging studies · High risk requiring full requalification · Like-for-like contingent on first-three-lot performance verification — each evaluated against documented evidence
Authorization Timestamp
February 14, 2024 — 10:25 EST
Regulatory Framework
21 CFR 211.100 · ICH Q9 · ICH Q10 · 21 CFR 211.180(e)
— Continued in the complete file —
Inspection Exposure Snapshot

Want the 483 observation language for your records?

The exact citation language an investigator uses when this gap appears. Sent to your inbox. Useful as a reference. No follow-up sales sequence.

No spam · Unsubscribe anytime

Continued · Part 03 of 03

The structure is clear. The example is published. The record itself is in the complete file.

See the complete authorization record.

A completed reference authorization record for the microcrystalline cellulose supplier change scenario. The blank template applied to your facility. The evidence checklist that closes the gap before inspection begins.

Show Me the Complete File →
✓ Free to read · Three commitment levels available

Used by Quality and Validation leaders preparing for FDA and EMA inspections. Built around 21 CFR 211.100 and ICH Q9.