APR / PQR

Annual Product Review / Product Quality Review

The APR (US) and PQR (EU) ask the same question from a year of data: is this product still being made consistently, and is the existing specification and process still appropriate? Both are annual, both are product-specific, and both are among the first documents an inspector requests — because a well-executed review reveals how well the whole quality system sees itself.

The EU review is the more prescriptive. GMP Chapter 1 lists what must be covered: starting and packaging materials, in-process and finished-product results, out-of-specification results and their investigations, all changes, variations to the marketing authorisation, stability results, returns/complaints/recalls, the adequacy of previous corrective actions, qualification status of equipment and utilities, and technical-agreement arrangements. The US requirement in 21 CFR 211.180(e) is briefer but has the same intent, adding an explicit expectation to evaluate whether specifications or procedures need changing.

What separates a real review from a compliance exercise is whether it draws conclusions. Compiling twelve months of tables is not a review; identifying that the same deviation recurred four times, that a supplier’s impurity profile drifted, or that a specification is now wider than the process actually needs — and raising actions from it — is. It should feed change control, CAPA, and continued process verification rather than being filed. Where a product is made for a marketing-authorisation holder by a contract manufacturer, the technical agreement must state who compiles and who evaluates it.

• —Annual and product-specific; US 21 CFR 211.180(e) (APR), EU GMP Chapter 1 §1.10 (PQR).
• —Covers materials, results, OOS, deviations, changes, variations, stability, complaints, returns, recalls, equipment status.
• —Must reach conclusions and raise actions — compiled data alone is not a review.
• —Explicitly evaluates whether specifications or processes should change.
• —Feeds CAPA, change control, and continued process verification; overlaps CPV data heavily.
• —For contract manufacture, the technical agreement must assign who compiles and who evaluates.

US: 21 CFR 211.180(e); EU: EudraLex Volume 4 Part I Chapter 1 §1.10 (Product Quality Review) with the responsibilities in Chapter 7 for outsourced activities; ICH Q7 §2.5 for active pharmaceutical ingredients; ICH Q10 for the linkage to continual improvement.