Product Quality Review
PQR
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A product quality review is the regular, typically annual, evaluation of a product's manufacturing and quality data to verify the consistency of the existing process, the appropriateness of current specifications, and to identify trends and any need for improvement. It reviews inputs such as starting materials, in-process and finished-product results, deviations, OOS results, changes, stability, returns, complaints, and recalls over the period. In the EU GMP framework it is the Product Quality Review; the US GMP equivalent is the annual product review.
The PQR is a trend-detector by design: individual batch dispositions can each look acceptable while the aggregate reveals drift, a rising deviation rate, or a specification that no longer fits the process. That aggregate, retrospective view is exactly what one-batch-at-a-time review cannot provide.
PQR outcomes feed CAPA, change control, and management review, and can trigger revalidation or specification changes — it is an input to the quality system, not a filing exercise.
- —Periodic (typically annual) review confirming process consistency and specification fitness
- —Aggregates batches, deviations, OOS, changes, stability, complaints, recalls
- —EU term PQR; US equivalent is the annual product review
- —Feeds CAPA, change control, and management review
EU GMP Chapter 1 Product Quality Review; US annual review under 21 CFR 211.180(e).
Frequently asked questions
What does Product Quality Review stand for?
Product Quality Review stands for PQR.
What is Product Quality Review?
A product quality review is the regular, typically annual, evaluation of a product's manufacturing and quality data to verify the consistency of the existing process, the appropriateness of current specifications, and to identify trends and any need for improvement. It reviews inputs such as starting materials, in-process and finished-product results, deviations, OOS results, changes, stability, returns, complaints, and recalls over the period. In the EU GMP framework it is the Product Quality Review; the US GMP equivalent is the annual product review.
Which regulations cover Product Quality Review?
EU GMP Chapter 1 Product Quality Review; US annual review under 21 CFR 211.180(e).