Product Quality Review (APQR/PQR) Training

About this course

Why the product quality review matters

FDA requires each drug product to be evaluated at least annually, under written procedures, to decide whether specifications or procedures need to change. EU GMP asks for regular reviews of every authorised product, including those made only for export, to verify consistency, highlight trends and identify improvements. Recent FDA warning letters show what happens when reviews are missing or are promised but never delivered, and when a firm's own data show a rising trend that nobody acts on. A review that only fills a template wastes a year of data; a good one is often the first place a slow drift becomes visible. The review also carries weight at inspection: FDA treats the written evaluation as a record it may inspect, not as an internal audit report.

What this course does differently

The course places 21 CFR 211.180(e) and EU GMP Chapter 1 side by side and names exactly where they differ: the length of the content list, scope, grouping, and who evaluates the results. It then builds one review for both regions, following JKL Pharma's metformin tablets chapter by chapter, from materials and suppliers to batches, deviations, changes, stability and complaints. Learners see how to trend rather than tabulate, how to link chapters so connections appear, and how to write conclusions that answer both regions' questions. Each topic ends with the common mistakes and what good practice looks like, and the draft revision of Chapter 1 is named clearly as a draft. The harder cases are covered too: what EMA expects in a year when a product was not made at all, when reviews may be grouped by product type and when grouping cannot be justified, how a chain of contracts must be reviewed, and how ICH Q7 applies the same idea to active substances. Every point is tied to the text it comes from, so a learner can check it at the source.

Who should take it

The course is written for QA and QC staff who compile or check reviews, production, engineering and technical staff who supply the data, regulatory affairs staff who contribute variations and commitments, and Qualified Persons and managers who approve the conclusions. It is equally useful for sites that supply both the US and the EU and need one review that satisfies both. Staff who are new to the review will learn the structure from the start, while experienced reviewers will find the regional differences, the trending methods and the follow-up of actions set out in more depth than a procedure usually gives. Teams that work with contract manufacturers or a separate authorisation holder will see how the technical agreement divides the work.

What you can do afterwards

Learners can plan a review with a justified period, data owners and a written procedure, including years with few batches or none. They can review materials, results, deviations, changes, qualification status, stability and market data, and turn trends into findings. They can write conclusions with actions that have owners and dates, decide when corrective action or revalidation is needed, agree responsibilities with an authorisation holder or contractor, and prepare the documents an inspector is likely to ask for. They can also open the previous year's actions and say whether each one worked, which is where many reviews fall short, and mark every change on a chart so that a shift can be linked to its cause.