What the inspector wrote
Management review records for the previous three years did not include supplier performance, the status of actions from previous reviews, or resource adequacy. The procedure listed the inputs required by ICH Q10 sections 3.2.4 and 4.1 but the review agenda and pack did not follow it. The head of quality stated that suppliers were covered in a separate meeting for which no records were available.
Why it was cited
ICH Q10 3.2.4 and 4.1 list the matters the review must assess. The list exists precisely so that the review cannot avoid the uncomfortable topics. Three consecutive years without supplier performance or previous actions is not an oversight; it is the shape of the review.
The 'covered elsewhere' defence fails when the elsewhere has no records and when the review's own procedure says otherwise. The inspector cites both the missing input and the departure from procedure.
What would have prevented it
- Compile every review pack against an input register built from ICH Q10 3.2.4 and 4.1, and record in the minutes any input that was not available and why.
- Make the status of previous actions the first agenda item at every review.
- Give resources a standing item with headcount against plan, vacancy duration and backlog in days, presented by the functions concerned.