What the inspector wrote
The Product Quality Review for Product Y (PQR-25-004) recorded twelve deviations during the period, of which eight related to tablet weight variation at compression on line C, a stability study in which the principal degradant had reached 0.42 per cent at 18 months against a shelf-life limit of 0.5 per cent, and two complaints of chipped tablets. The conclusion stated that 'the process is considered to be in a state of control, the specifications remain appropriate and no corrective or preventive actions are required'. The conclusion was identical in wording to that of the previous year's review. No assessment of whether CAPA or revalidation was required had been documented.
Why it was cited
Paragraph 1.11 requires the results of the review to be evaluated and an assessment made of whether corrective and preventive action or any revalidation should be undertaken. The body of this review supplied every reason to raise actions; the conclusion ignored all of them. The identical wording to the previous year told the inspector the conclusion was a template, not an evaluation.
Inspectors treat this as more serious than a missing section, because it shows the site's own review mechanism cannot be relied on to detect its own problems. It calls into question every other conclusion the quality system reaches.
What would have prevented it
- Structure the conclusion as explicit answers to the three questions in 1.10 (consistency, specifications, improvements), each carrying this period's numbers and events.
- Require the reviewer and the QP to check the conclusion against a summary of findings from each of the twelve sections before signing; a conclusion of 'no actions' must state what was considered and why nothing is needed.
- Prohibit copying the previous year's conclusion; make comparison with the previous review an explicit step in the review checklist.