APQR vs PQR: What's the Difference?
2026-07-01
APQR vs PQR explained — are they the same? The US 'Annual Product Quality Review' and the EU 'Product Quality Review', what each requires, and how they line up.
Ask two quality professionals whether APQR and PQR are the same thing and you'll often get two different answers. The confusion is understandable — they come from different regulators — but for practical purposes the answer is simple.
APQR and PQR are essentially the same exercise under two names. "Annual Product Quality Review" (APQR) is the common US/industry term rooted in the FDA's annual-review requirement; "Product Quality Review" (PQR) is the term defined in EU GMP. Both are a periodic — usually yearly — review of a product's manufacturing and quality data to confirm the process stayed in a state of control.
Full forms
- APQR — Annual Product Quality Review (also written PQR, or "Annual Product Review", APR)
- PQR — Product Quality Review (the EU GMP term)
(In welding, "PQR" means Procedure Qualification Record — a completely unrelated term. This article is about the pharma quality review.)
Where each comes from
- APQR (US) — the FDA requires, under 21 CFR 211.180(e), a written record reviewed at least annually to evaluate the quality standards of each drug product and decide whether to change specifications, manufacturing or control procedures. The regulation doesn't use the letters "APQR" — industry coined the term for the annual review.
- PQR (EU) — EU GMP Chapter 1 (Part I, sections 1.10–1.11) requires a regular, periodic Product Quality Review of all licensed products, and spells out — in a numbered list — exactly what it must cover.
- WHO and most other GMP frameworks require the same review under similar wording.
What's the same
For a company supplying both markets, 95% of the work is identical. Both reviews look, product by product, at:
- All batches made in the period, with yields and disposition
- Starting and packaging materials
- Critical in-process and finished-product results, and their trends
- Out-of-specification (OOS) results and their investigations
- Deviations, non-conformances and the effectiveness of the resulting CAPAs
- Changes to processes, methods and equipment
- Returns, complaints and recalls
- Stability data and any adverse trends
- Qualification/validation status of relevant equipment and utilities
The subtle differences
- How prescriptive it is. The EU PQR explicitly lists its required elements (including a review of marketing-authorisation variations submitted/granted/refused, and the adequacy of technical/quality agreements for contract manufacturing). The US requirement is shorter and less prescriptive — but in practice good APQRs cover the same ground.
- The name and cadence emphasis. "APQR" bakes annual into the name; the EU says regular/periodic (annual is the norm). Both land at roughly once a year per product.
- Marketing authorisation focus. The EU explicitly wants a check that the dossier/registration is still accurate (post-approval commitments, variations). US firms fold this in too, but it's called out more clearly in the EU text.
Do you need to do both?
No — you do one review that satisfies both. A site shipping to the US and EU typically runs a single combined APQR/PQR per product, structured to meet the EU's explicit element list (which is the stricter of the two) so it automatically covers the US requirement. Call it whatever your SOP calls it; make sure it hits every EU element.
The bottom line
Same purpose, same data, same annual rhythm — different regulator, different name. If your review already meets EU GMP Chapter 1, you're compliant with the FDA's annual-review expectation too.
Frequently Asked Questions
Is APR the same as APQR?
Yes. "Annual Product Review" (APR) and "Annual Product Quality Review" (APQR) are used interchangeably for the same US review.
Does the FDA require an "APQR"?
It requires the annual review in 21 CFR 211.180(e). "APQR" is the industry name for that review, not the regulation's wording.
How often is a PQR done?
Regularly — in practice, once a year per product, though trending is best done continuously through the year.
Who owns the APQR/PQR?
QA owns it, pulling data from production, QC, engineering and regulatory. It's approved by the Quality unit.