Dealing with a GMP problem now?
Something has happened, and the timeline may no longer be yours. These pathways set out what to consider first, what evidence must not be lost, and the mistakes sites most often make under pressure.
Do not reconstruct records retrospectively. Whatever the pressure, recreating a record after the fact converts a quality problem into a data integrity problem — a different and far more serious order of finding.
What are you dealing with?
An inspection finding or critical observation
A response letter is a set of commitments to a regulator on a fixed timetable — its credibility matters as much as its content.
Open the pathwayA major or critical deviation
The question that decides the investigation is not what happened, but what else shares the same cause.
Open the pathwayA data integrity concern
Handle the investigation itself carefully — a mishandled data integrity enquiry can create a second, worse problem.
Open the pathwayAn out-of-specification result
An OOS result stands as valid unless a documented, assignable laboratory cause explains it.
Open the pathwayA batch failure or batch hold
Establish product impact and supply consequence in parallel, because the timelines for each are different.
Open the pathwayA supplier or CMO failure
Assess product impact and contractual position in parallel — the quality agreement usually determines what you can require.
Open the pathwayTen steps, in this order
- 01
Contain
Stop the situation getting worse. Quarantine affected material, halt the process step if continuing would compound the problem, and secure the area or system involved.
- 02
Assess
Establish what is known versus assumed. What happened, when, to what, and who observed it. Resist the pull to conclude a cause in the first hour.
- 03
Escalate
Notify according to your own procedure. Getting the right people informed early costs little; discovering later that QA or the QP was not told is itself a finding.
- 04
Investigate
Establish the cause with evidence rather than plausibility. Depth should be proportionate to risk, but the standard for a confirmed cause does not move.
- 05
Document
Record contemporaneously as you go. Reconstructing a record afterwards converts a quality problem into a data integrity problem, which is a different order of seriousness.
- 06
Determine impact
Assess product impact beyond the batch in front of you — other batches sharing equipment, materials, personnel or time window, and material already released.
- 07
Correct
Fix the immediate instance, and separately address the cause. Conflating correction with corrective action is the most common weakness in a response.
- 08
Prevent recurrence
Address why the process permitted the event. Where the design invites the error, training a person not to make it is a delay rather than a correction.
- 09
Verify effectiveness
Check against a criterion defined before implementation. This is the step most often skipped, and the one that decides whether the event returns as a repeat finding.
- 10
Close and monitor
Close with evidence attached, and keep the indicator under review long enough to know the fix held rather than merely completed.
This is quality guidance, not legal advice
This is practical quality guidance, not legal or regulatory advice. Whether a specific event triggers a particular regulatory obligation depends on the product, the market, the marketing authorisation and the facts. Assess against your own procedures, and take qualified advice where the situation may involve notification, recall or a deliberate act.
Bring the specific problem you have
If there is a response deadline, an open investigation or a batch decision waiting, fifteen minutes is usually enough to establish what to do first.