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Annual Product Quality Review (APQR) Outline Template

The annual product quality review checks every year whether a product's process and specifications remain appropriate. This outline lists the sections reviewers expect so you can collect data once and write the report with less rework.

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Company

Product and strength

Review period

Batches manufactured

Batches rejected

Prepared by

Report date

Key findings summary

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GMP Annual Product Quality Review Outline Template

Annual Product Quality Review

Company: Acme Pharma Ltd Product: Amlodipine 5 mg tablets Review period: 1 Oct 2025 to 30 Sep 2026 Prepared by: QA Specialist Date: 2026-10-20

1. Summary

Batches manufactured: 24 Batches rejected: 0

All batches met specification. Two minor deviations on tablet weight variation closed with no product impact. One packaging supplier change completed under change control.

2. Data reviewed

Section	Content to review	Finding	Action
Starting materials	Materials used and supplier changes, with trends of test results
In-process controls	Critical in-process control results and critical parameters
Finished product	Release results, trend charts and out of trend results
Rejected and reprocessed batches	Reasons and investigations
Deviations	Number, type and root cause, recurrence
OOS and OOT results	Investigations and conclusions
Changes	Process and analytical changes under change control
Stability	Ongoing stability results and any trends
Complaints, recalls and returns	Number, cause and corrective action
Marketing authorisation	Variations submitted, approved or refused
Qualification status	Equipment and utilities qualification status
Contract givers and acceptors	Technical agreements current

3. Conclusions and recommendations

State whether the process is in a state of control, whether specifications remain appropriate, and list corrective actions with owners and dates.

Approvals

Prepared by / Date

Production head / Date

QC head / Date

Head of QA / Date

A skeleton aligned with the topics in EU GMP Chapter 1 (product quality review) and 21 CFR 211.180(e) annual review. Add your own data tables, trend charts and document numbers before approval.

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How to use the outline

Enter the product, review period and headline figures, then export to Word. For each row of the data table, attach the trend chart or listing and write the finding. Pull batch numbers, deviations and change control records from your quality system and ERP before you start writing. Finish with conclusions that say whether the process is in control and what actions follow.

Start the data pull at least two months before the due date
Group similar products into one review only when justified
Give every action an owner and date

What the regulations require

EU GMP Chapter 1 requires regular periodic or rolling quality reviews of all authorised medicinal products, to verify consistency of the process and the appropriateness of specifications and to highlight trends. 21 CFR 211.180(e) requires an annual evaluation of records for each drug product. The topics in the table follow those lists. Reviews should also cover the status of corrective actions from the previous review.

Common mistakes

Typical weaknesses are reports that only list numbers with no conclusion, missing trending, no check of last year's actions, and late completion. A good APQR also looks at trends below the specification limit, because drift in assay or dissolution can appear well before a failure. Include capability indices where data allows, and be honest about uncertainty when the sample is small.

Trend critical quality attributes, not only pass or fail
Check that last year's actions were completed
Complete the review on time and keep it with the product file

Frequently Asked Questions

Is APQR the same as PQR?

In practice yes. EU GMP uses product quality review, many sites call it APQR for annual product quality review, and the US rule calls it an annual record review. The content overlaps strongly.

Can I combine strengths in one report?

Often yes, when the process and specification are the same apart from strength and the data can be shown per strength. Document the rationale and make sure trends for each strength are visible.

Who approves the APQR?

Quality assurance normally owns it, with review by production and QC. Your procedure defines signatories. The conclusions should be reviewed by someone with authority to decide on corrective actions.

How is it linked to revalidation?

The review should state whether revalidation or requalification is warranted. Negative trends or significant changes can prompt this. Link actions to change control.

If assembling APQR data from ERP batch records, QMS and LIMS takes weeks every year, Netray can help build a read-only extraction that fills the tables for review.

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