What the inspector wrote
The Product Quality Review for Product X (PQR-25-011) presented finished product and critical in-process results for 40 batches in tabular form with a conformance column. No control charts, control limits, capability assessment or comparison with the previous review period were included for any parameter. The review concluded that 'the process remains in a validated state of control'. On review of the tabulated data, dissolution at 30 minutes had declined from a mean of 91 per cent in the first quarter to 84 per cent in the fourth quarter against a limit of not less than 80 per cent. This trend was not identified in the review.
Why it was cited
Paragraph 1.10 defines the objective of the review as verifying consistency and highlighting trends. A table with a pass column verifies conformance, which was already established at release, and highlights nothing. The claim 'state of control' is a statistical statement that requires a control chart to support it.
The inspector found the trend in the site's own table in a few minutes. That is the damaging part: it shows that nobody at the site looked at the data they had collected, which raises the question of what else the quality system is not looking at.
What would have prevented it
- Require an individuals and moving range chart with specification and control limits for every critical finished product and in-process parameter, plus a capability index, in every PQR, with the rules applied written into the procedure.
- Require a written evaluation sentence under every chart: mean, spread, rules triggered, comparison with the previous period, and what follows.
- Run the trending monthly under an Annex 15 ongoing process verification plan so the PQR summarises evaluation that has been happening all year rather than attempting it once.