Annual Product Quality Review (APQR): What to Include

An Annual Product Quality Review (APQR), called a Product Quality Review (PQR) in EU GMP and an Annual Product Review (APR) in US regulations, is a documented yearly review of all quality data for a product. Its purpose is to confirm that the process is consistent, that specifications remain appropriate and to identify trends and improvements.

Done well, the APQR is where scattered deviations, results and complaints come together into one picture. Done badly, it becomes a thick compilation of tables that nobody reads, and inspectors notice the difference quickly.

The regulatory basis

In Europe, EU GMP Part I, Chapter 1 (Pharmaceutical Quality System) requires regular periodic or rolling quality reviews of all authorised medicinal products, including export-only products, normally conducted annually. The PIC/S GMP guide contains equivalent text, which matters for many GCC and Indian manufacturers that follow PIC/S-style GMP.

In the US, 21 CFR 211.180(e) requires that records be evaluated at least annually to determine whether specifications or manufacturing and control procedures need to change. It names a review of a representative number of batches, plus complaints, recalls, returned or salvaged products and investigations.

For active substances, ICH Q7 includes a section on product quality reviews. India's revised Schedule M and other national GMP rules also expect a periodic product review. Always check the current text that applies to your site and your export markets.

What to include in an APQR

The EU list is the most detailed, so many sites build their template around it and add any US-specific items. The table below maps each section to its usual data source and what reviewers should look for.

Some sites add process validation status, annual yield and reconciliation data, and the number of batches made, released and rejected. These are useful context, especially for the conclusions.

Trending: the part that adds value

Listing results is not a review. The APQR should show whether the process is stable and capable, and that means trending. Plot critical quality attributes and key in-process results batch by batch, with specification limits and, where you use them, alert limits.

Practical approaches include control charts with defined rules for runs and shifts, process capability indices for attributes with enough data, and comparison with the previous year's review. Group data by factors that might explain variation: equipment train, API supplier, manufacturing site or campaign.

If you have too few batches for meaningful statistics, say so and use simpler visual review. Do not present capability indices calculated from three batches as though they mean something. The link between trending and investigations is covered in our guide to OOS vs OOT results.

Conclusions, actions and ownership

The most important page of an APQR is the conclusion. EU GMP expects the manufacturer and, where different, the marketing authorisation holder to evaluate the results and decide whether corrective and preventive action or revalidation is needed, with documented reasons. Management should then make sure agreed actions are completed and effective.

A good conclusion section states clearly:

• whether the process remains in a state of control
• whether specifications and methods remain appropriate
• which trends need action, with owners and target dates
• whether revalidation or a change control is required
• the status of actions from the previous review

Ownership is usually with QA, which coordinates the review, but data and interpretation must come from production, QC, engineering, regulatory affairs and supply chain. Where the manufacturer and marketing authorisation holder are different companies, the technical agreement should define who prepares and approves the review. Actions should feed into the CAPA and change control systems described in deviation vs change control vs CAPA.

Worked example: a dissolution trend in a tablet APQR

A solid oral dosage site in Ahmedabad prepares the APQR for an immediate-release tablet with a dissolution specification of not less than Q = 80% at 30 minutes. All 46 batches in the review period met the specification, so the product looks fine at first glance.

1. Trend found: plotting mean dissolution batch by batch shows a gradual downward shift. Early batches averaged around 92%, later batches around 85%. No result failed, but the margin to the limit has narrowed.
2. Correlation: the reviewer groups batches by input factors. The shift starts with batches using binder from a second approved supplier, added mid-year through change control.
3. Cross-check: the change control had included three exhibit batches that passed dissolution, but no ongoing comparison was planned. Stability data for the new-supplier batches show slightly lower dissolution at the six-month point, still within specification.
4. Conclusion: the process is within specification but shows an adverse trend linked to the material change. Capability for dissolution has dropped.
5. Actions: QA opens a CAPA to compare binder properties between suppliers, QC adds the new-supplier batches to enhanced stability monitoring, and the change control is reopened to define acceptance criteria for the binder attribute that matters. Owners and target dates are recorded.

Without the trend chart, this drift might only have been noticed when a batch failed.

Common mistakes

• Compiling data without trending or interpretation.
• Writing the same conclusion every year regardless of the data.
• Starting the review too late, so it is rushed and approved months after the period ends.
• Ignoring batches that were rejected or are still under investigation.
• Not checking whether CAPA from the previous review were effective.
• Leaving out contract manufacturing, testing or packaging sites.
• Raising actions with no owner, date or link to the CAPA system.

Key takeaway: An APQR is not a data dump. Use it to trend, connect and conclude, and make sure every adverse trend leads to a clear, owned action.

Frequently Asked Questions

What is the difference between APQR, PQR and APR?

They describe the same activity under different regulations. PQR, or Product Quality Review, is the term in EU GMP Chapter 1. APR, or Annual Product Review, comes from US 21 CFR 211.180(e). APQR is a common combined term used by many Indian and GCC manufacturers whose single review is designed to meet both sets of requirements.

How often must a product quality review be done?

EU GMP expects reviews normally annually, and US regulations require evaluation at least annually. Many sites run a fixed calendar cycle, while others use rolling reviews spread through the year. Either approach can work if every product is covered and the review is completed promptly. Check the requirements of your regulator and export markets.

Who is responsible for preparing the APQR?

QA usually coordinates and approves the APQR, but production, QC, engineering, regulatory affairs and supply chain provide the data and help interpret it. Where the manufacturer and marketing authorisation holder differ, the technical agreement should define who prepares, reviews and approves the report. Senior management should review the conclusions and support the resulting actions.

Can products be grouped in one APQR?

EU GMP Chapter 1 allows reviews to be grouped by product type, such as solid or liquid dosage forms or sterile products, where this is scientifically justified. The justification should be documented, and data should still be presented so that trends for each product remain visible. Confirm the approach with your QA policy and, if needed, your regulator.

What happens if the APQR finds an adverse trend?

The trend should be evaluated and, where needed, lead to CAPA, change control or revalidation, with documented reasons for the decision. A trend does not automatically mean a recall or batch rejection, but it does require a risk-based assessment of product already on the market and an owner for the follow-up actions.

Next steps

To build the investigation and trending skills a strong APQR needs, look at our Root Cause Analysis & CAPA course and Good Documentation Practices & Data Integrity Essentials. For related reading, see OOS vs OOT results, process validation stages explained and quality KPIs that actually drive improvement. You can also speak to a counsellor about the right course for your role.