[ SCENARIO · FREE · DETERMINISTIC ]
A Critical Supplier Audit Finding
An audit of your active-ingredient supplier finds that its laboratory’s results cannot be trusted, and you have been releasing its material on its certificates. Decide what happens to the lots in quarantine, the product already on the market, and the supplier.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
A company that supplies a key ingredient was found to be handling its test results badly. You have been trusting those results instead of testing everything yourself. You decide what to do with the ingredient you have, the medicine already made with it, and the supplier.
Under 21 CFR 211.84(d)(2), a manufacturer may accept a supplier’s report of analysis in place of its own testing only if it runs at least one specific identity test and has established the reliability of the supplier’s analyses. EU GMP Chapter 5 sets out similar conditions for reduced testing, and requires audits of active-substance manufacturers with deficiencies identified and corrective actions implemented.
Reduced testing is a credit extended to a supplier on evidence. A critical audit finding withdraws that evidence. The organisation then finds out whether it ever knew what the credit was resting on.
You are the supplier quality associate at a finished-dose manufacturer. Your auditor has just returned from the active-ingredient manufacturer.
The finding is critical: in the supplier’s QC laboratory, chromatography sequences were run and not reported before the official runs, and the audit trail was switched off for a period. Your site releases this ingredient on the supplier’s certificate plus its own identity test. Three lots are in your quarantine. Lots received over the past year went into finished batches that are now on the market.
The three quarantined lots have passing certificates and passing identity tests. Production needs one of them on Monday.
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across containment · assurance · impact · governance — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
WHAT THE CORRECT PATH RESTS ON
The primary sources behind the debriefs. The authoritative text lives at each official source.
- 21 CFR 211.84 — testing and approval of components; when a supplier report of analysis may be relied on ↗
- 21 CFR 211.192 — investigations extended to other batches ↗
- ICH Q10 — Pharmaceutical Quality System, §2.7 management of purchased materials ↗
- ICH Q7 — GMP for Active Pharmaceutical Ingredients, §6.60 laboratory records (the supplier’s own obligations) ↗
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →DO IT FOR REAL
- HOW-TO GUIDEHow to Qualify a Supplier →Rebuild the basis on which a certificate of analysis can be trusted.
- TEMPLATESupplier Quality Agreement →Set out what the supplier must notify and what you will test.
- HOW-TO GUIDEHow to Investigate a Data Integrity Breach →Work through laboratory data that cannot be trusted.
KEEP PRACTISING
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