APQR Format & Template: Section by Section
2026-07-01
An APQR format covering every required section — batches, deviations, OOS, changes, stability, complaints, returns, recalls — with what to put in each, plus a template structure.
Once you know what an Annual Product Quality Review is, the next question is always the same: what exactly goes in it, and in what order? Here's a section-by-section APQR format you can adapt into your own template — built to satisfy the explicit element list in EU GMP Chapter 1, which also covers the FDA's annual-review requirement.
A complete APQR reviews, product by product, a defined set of manufacturing and quality data for the period — every batch made, all deviations and OOS results, changes, stability data, complaints, returns and recalls — and concludes whether the process stayed in a state of control.
The sections an APQR must contain
1. Report identification & scope
Product name, strength, dosage form, review period (from–to), report number, and the list of markets/registrations covered. State who prepared, reviewed and approved it.
2. Batches manufactured
A list of every batch made in the period — batch number, size, manufacturing date, yield, and disposition (released / rejected / on hold / recalled). This is the backbone the rest of the review trends against.
3. Starting & packaging materials
Suppliers used, any new/qualified suppliers, rejected lots, and any supplier-quality issues. Confirm materials came from approved sources.
4. Critical in-process & finished-product results
Key in-process controls and finished-product test results, presented as trends (not just pass/fail) — e.g. assay, dissolution, weight, hardness. Flag any drift toward a limit even where nothing failed.
5. Out-of-specification (OOS) results
Every OOS in the period, its investigation outcome, and any impact on release. Link to the OOS investigation records.
6. Deviations & non-conformances
All significant deviations, their root causes, the CAPAs raised, and — importantly — an assessment of whether previous CAPAs were effective. Repeat deviations are a red flag the review must surface.
7. Changes (change control)
All changes to the process, analytical methods, equipment or specifications during the period, and confirmation they were made under change control and validated where required.
8. Returns, complaints & recalls
Quality-related returns, market complaints (with trends and investigations), and any recalls. A rising complaint category is exactly what an APQR is meant to catch early.
9. Stability data & trends
Results from ongoing/commitment stability studies, any out-of-trend (OOT) results, and confirmation the assigned shelf life still holds.
10. Qualification & validation status
The qualification status of critical equipment and utilities (HVAC, purified water, compressed gases) and the validation status of the process and analytical methods.
11. Marketing-authorisation variations
Post-approval commitments, and any MA variations submitted, granted or refused in the period — confirming the registered dossier still matches how the product is actually made and tested.
12. Technical / quality agreements
For contract manufacturing or testing, confirm the technical/quality agreements are current and being met.
13. Conclusion & recommendations
The heart of the report: a clear statement of whether the process remained in a state of control, the trends observed, and the CAPAs / actions for the next period (e.g. tighten a spec, requalify a supplier, revalidate a step).
A template structure at a glance
1. Cover & sign-off (prepared / reviewed / approved, dates)
2. Scope & product details
3. Sections 2–12 above, each with data + a short narrative conclusion
4. Overall conclusion & action plan
5. Appendices (batch list, trend charts, raw data references)
Common mistakes
- A data dump with no conclusions. Tables without a "what does this tell us" narrative fail the point of the review.
- Doing it as a year-end fire-drill. Pulling 12 months of records in one week guarantees gaps; trend continuously.
- Ignoring CAPA effectiveness. The review must judge whether last year's fixes actually worked.
- Missing the MA/dossier check (a common EU PQR gap).
From year-end spreadsheet to continuous APQR
Most of the pain is the gathering — chasing batch lists, deviations, OOS, complaints and stability results out of separate registers and spreadsheets. When those live in one connected system, the APQR is a matter of selecting a product and a period and letting the data assemble itself, with every figure traceable to its source record. That's how Flobri turns the annual APQR into a continuous, always-ready view.
Frequently Asked Questions
Is there a mandatory APQR format?
No single mandated layout — but EU GMP Chapter 1 lists the elements it must cover, so any compliant format includes the sections above.
Who prepares the APQR?
QA compiles it from production, QC, engineering and regulatory inputs; the Quality unit approves it.
What period does an APQR cover?
Typically a rolling 12 months per product, though the exact window is defined in your SOP.
APQR vs PQR — which format do I use?
The same one. See APQR vs PQR — build to the EU element list and it covers both.