Findings library

One management review finding a week, taken apart

Written from the deficiency categories regulators publish, not from named reports. Each entry shows the observation in the inspector's style, why it was cited, and the practice that would have prevented it.

MajorModule 1 15 Sept 2026

No evidence that senior management was aware of a significant quality issue

Pharmaceutical quality system: senior management responsibility

The complaint rate for product X increased in each of the four quarters preceding the inspection and a confirmed root cause (closure supplier change) was identified by the complaints unit in month five. Neither the trend nor the root cause appeared in any management review record. The site head, when asked, was not aware of the trend. No decision on the supplier had been taken at the time of inspection.

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MajorModule 2 8 Sept 2026

Management review did not include required inputs

Management review: inputs incomplete against ICH Q10

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.

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MajorModule 5 1 Sept 2026

Review actions with no owner, no date and no evidence of completion

Management review: outputs not defined or not followed up

Minutes of the management review recorded eleven actions, of which seven had no named owner and nine had no due date. Four actions from the previous year's review were recorded as closed with no evidence of completion. The action 'improve CAPA effectiveness' had been carried forward unchanged for three consecutive reviews. No effectiveness of any completed action was reported.

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MajorModule 4 25 Aug 2026

Management review held less frequently than the procedure required

Management review: frequency and escalation

The site procedure required management review at least every twelve months. The interval between the two most recent reviews was nineteen months. During that interval the site received a critical finding from a customer audit and initiated a product recall. Neither event triggered a review and no mechanism for an unscheduled review was defined.

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OtherModule 6 18 Aug 2026

Review records consisted of slides and an attendance sheet, with no record of decision

Management review: records do not demonstrate effectiveness

Records of management review consisted of the presentation used at the meeting and a signed attendance list. There was no record of discussion, of conclusions reached on any input, of the review's assessment of the suitability and effectiveness of the quality system, or of decisions on resources. The head of quality described several decisions taken at the meeting that did not appear in any record.

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