Paragraph 1.10 of EU GMP Chapter 1 says the review 'should include at least' twelve things. The phrase 'at least' matters: the list is a floor, not a template. But the list is where inspectors start, because it is easy to check. This guide takes each item in turn and gives the question it is really asking, the data source, and the sentence that is the difference between a section that complies and a section that merely exists.
(i) Starting materials and packaging materials
The text: 'a review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances'. The question is whether what went into the product was what the dossier says, from where the dossier says, at the quality the specification says. Data: incoming test results by supplier and lot, certificate of analysis conformance, supplier changes, new sources qualified in the period, and for the active substance the supply chain documented back to the registered manufacturer. A compliant section lists each material, each supplier, the number of lots, any results at or near limits, and any change of source. A section that says 'all starting materials were tested and complied' has not reviewed traceability and has not looked at trends by supplier.
(ii) Critical in-process controls and finished product results
This is the heart of the review and the section that answers 'is the process consistent'. Data: every critical in-process control result and every finished product result for every batch, by test. A compliant section shows each critical parameter as a trend over the period, states the mean and spread, states whether any run rule was triggered and whether any result was out of trend, and compares capability against the specification. It also confirms which parameters are defined as critical and where that definition lives. A table of results with 'all within specification' is the single most common weak section in the whole document. The trending guide on this site covers how to do it properly.
(iii) Batches that failed specification and their investigation
All of them: rejected, reprocessed, reworked. For each: the batch, the test, the result, the OOS investigation reference, the confirmed cause, the disposition and whether the cause was manufacturing or laboratory. Then, across them: is there a pattern by test, by line, by shift, by material lot? If there were none, say so, and say that the OOS log was reviewed to confirm it.
(iv) Significant deviations, investigations and CAPA effectiveness
The text asks for 'all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventive actions taken'. Three things, not one. Sites list the deviations. Fewer summarise the investigations. Almost none evaluate whether the CAPA worked. A compliant section classifies deviations by failure mode and area, identifies repeats, and for CAPA closed in the period states the effectiveness check result. Note 'significant': if your procedure defines a minor category that is excluded, the exclusion must be defensible, and the number of minor deviations should still be reported and trended, because a rising count of minor events is itself a trend.
(v) Changes to processes or analytical methods
Every change control affecting the product, the process, the equipment, the methods or the specifications, with its status and, where closed, whether its effectiveness was assessed. The evaluation question: has any change shifted the trend in (ii)? This is where the PQR earns its keep. If a granulation end-point was changed in May, the disintegration results before and after should be compared, and the sentence that does so belongs here.
(vi) Marketing authorisation variations
Submitted, granted or refused, including third-country dossiers. Data comes from regulatory affairs, which is why this section is often empty at contract manufacturers: they do not hold the information. The technical agreement must say who supplies it. The evaluation question is whether the site is manufacturing to the currently approved dossier: a granted variation that changes a specification should be visible in the specification used for release in (ii).
(vii) Stability monitoring results and adverse trends
All ongoing stability studies with time points pulled in the period: study, batch, condition, results to date, and a statement on trend. 'Adverse trend' means a result moving towards a limit at a rate that would breach it within the shelf life, whether or not it has breached it yet. A section that lists studies and says 'all results within specification' has not answered the question the paragraph asks.
(viii) Returns, complaints and recalls
All quality-related returns, complaints and recalls, with the investigations performed at the time. Classify complaints by type and confirm each was investigated. The evaluation question is whether complaints point at something the batch data did not detect. Three complaints of a broken blister seal in a year with no packaging deviation is a finding the PQR should raise, not the inspector.
(ix) Adequacy of previous corrective actions
Every action raised in the previous review: status, evidence of completion, and whether it achieved its purpose. This is the item most often marked 'not applicable'. It is applicable whenever the previous review raised anything, and if the previous review raised nothing, the current review should ask why. An inspector reads the two reports side by side; make sure they line up.
(x) Post-marketing commitments
For new authorisations and variations: any commitment made to a regulator (additional stability, a method validation, a process study) and its status. Again the data sits with regulatory affairs or the MAH. If there are none, say so and say who confirmed it.
(xi) Qualification status of equipment and utilities
The text gives examples: HVAC, water, compressed gases. The question is whether everything the product touches was in a qualified state throughout the period. Data: the requalification schedule, its completion, any overdue items, any qualification-related deviation, and the calibration status of critical instruments. A list of equipment with 'qualified' next to each is not a review; the review is the confirmation that periodic requalification was performed on time and that the results supported continued use.
(xii) Contractual arrangements
A review of the technical and quality agreements defined in EU GMP Chapter 7, to confirm they are current. Every contract laboratory, contract manufacturer, contract packager, contract sterilisation site and storage provider involved in the product: agreement reference, date, and a statement that it still reflects the actual arrangement. Agreements that predate a change of scope, a site move or a new activity are the usual finding.
Module 2 of the course works through all twelve sections with a data-source map, a section template for each, and a bank of weak and defensible examples taken from real reviews.