APQR

An Annual Product Quality Review (APQR, called a Product Quality Review or PQR in EU GMP) is the periodic evidence that a product's process remains in a state of control. Two regimes drive it. In the US, 21 CFR 211.180(e) requires a written record reviewed annually covering a representative number of batches, whether approved or rejected, plus complaints, recalls, returns, salvages and investigations. In the EU, EU GMP Chapter 1.10 is more prescriptive: starting and packaging materials, in-process and finished results, out-of-specification investigations, changes, variations, stability, returns/complaints/recalls, equipment qualification status, technical agreements and the effectiveness of previous corrective actions.

The review is not a data dump. It has to reach a conclusion — is the process capable, are the specifications still appropriate, and does anything need corrective action or revalidation. That conclusion is signed by the quality unit (and, in the EU, assessed with the Marketing Authorisation Holder where they are a different legal entity). Trend evidence matters more than individual results: yield distribution, Cp/Cpk, out-of-trend events, deviation recurrence and complaint rate per unit shipped.

What makes an APQR expensive is not the analysis but the assembly. Where batch records are paper and results live in a separate LIMS, the six weeks of the review period are spent extracting, transcribing and reconciling — and the number in the report is then a second-generation copy that an inspector will test against source. Where execution, QC results, deviations, changes and complaints share one record, the review compiles from the source data itself and the analyst spends their time on the conclusion.

In V5 Ultimate the APQR is generated from live execution data: every batch made in the period, its yields and in-process results, linked deviations and CAPAs, change controls affecting the product, stability pulls, complaints and returns — with the trend charts computed rather than pasted. The output is a versioned, signed document with each figure traceable back to the record it came from. See APQR / PQR software for how the compilation works, and CPV for the continuous counterpart.