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1. Scope, period and schedule

Product(s) or group named, with the grouping rationale stated where products are grouped
Review period stated, contiguous with the previous review, with the data cut-off date
Report is within the procedural deadline, or a documented extension was approved before the due date
All batches in the period listed and reconciled against LIMS, the batch register and the release log
Products with no batches in the period still reviewed, with the absence of batches stated

2. Starting and packaging materials (i)

Every material listed by supplier with the number of lots received and any results at or near limits
New sources and supplier changes in the period identified and their qualification referenced
Active substance supply chain traceability confirmed back to the registered manufacturer
Incoming results trended by supplier where more than one source is used

The list of critical parameters is stated, with the document that defines them
Each critical parameter plotted in batch order with specification and control limits
Mean, spread and capability reported for each; the basis for control limits stated
Rules applied are named; every rule triggered and every OOT result is reported
Current period compared with the previous period for each parameter
An evaluation sentence written under every chart

All batches that failed specification listed with the OOS investigation, cause and disposition
All significant deviations listed and classified by failure mode and area
Repeat failure modes identified and compared with the previous period
Effectiveness of CAPA closed in the period evaluated, not just listed

All change controls affecting the product, process, equipment, methods or specifications listed with status
Effect of each implemented change on the trended data assessed and stated
Variations submitted, granted or refused in the period listed, including third-country dossiers
Source of variation data (MAH or regulatory affairs) named, with the date it was supplied

Every ongoing stability study with time points in the period listed with results to date
Each study assessed for adverse trend against the shelf-life limit, not just for conformance
All quality-related complaints classified by type, each with its investigation reference
Returns and recalls listed with the investigation performed at the time
Complaints compared with batch data for anything release testing did not detect

Every action from the previous review tabled with status, evidence of completion and effectiveness
No action from the previous review is missing or marked 'not applicable' without explanation
Post-marketing commitments listed with status, or their absence confirmed by a named source

Requalification of relevant equipment and utilities confirmed as performed on time, with any overdue items named
Calibration status of critical instruments confirmed for the period
Every quality and technical agreement for the product listed with reference and date, and confirmed current
Agreements predating a change of scope, site or activity flagged for revision

Conclusion answers consistency, appropriateness of specifications and improvements separately, with this period's numbers
Conclusion is consistent with every section of the body
Conclusion is not a copy of the previous year's
Need for CAPA or revalidation explicitly assessed and the decision recorded
Every action has a reason, an owner, a due date and a route into CAPA, change control or the OPV plan

Signature page states what each signature means; dates are in a sensible order
QP responsible for certification has reviewed and signed
MAH evaluation documented where the MAH is not the manufacturer, and provided to the certifying QP
Summary and actions tabled at management review, with the date
PQR action management included in the self-inspection programme