The product quality review library of the GMP Training Academy
productqualityreview.com is one of a family of topic sites run by The GMP Training Academy, an initiative of Truex Consultancy B.V. in Amersfoort, the Netherlands. Each one goes deep on a single part of the quality system and points to the course that teaches it.
Because the product quality review deserves more than a course page
Most GMP training sells a course and stops. We wanted a place where the free material is genuinely useful on its own: guides you can use in this year's review, a checklist QA and the QP can run today, and a findings library that shows what actually gets cited. If that is all you take from here, good. If you want the full method with practice and a certificate, the course is on the academy.
Four rules
If it would not hold up in an inspection, it is not here
Every practice on this site is one we would defend in the room. Where the regulation is silent we say so, and where sites commonly get away with less, we still teach the defensible version.
Regulation quoted, not paraphrased
Each guide and glossary term cites the clause. You should be able to take any statement here to your QA head with the reference attached.
Written from findings, not from slides
The course and the guides start from what regulators actually cite in product quality reviews and work back to the practice that would have prevented it.
One system, not a silo
The PQR draws on deviations, CAPA, change control, stability and qualification, and feeds management review and Annex 15 ongoing process verification. The course teaches the connections because that is how inspectors read the report.
One academy, one certificate standard, many topics
The GMP Training Academy runs courses on deviation management, change control, CAPA, data integrity, product quality review, management review and more. Every course uses the same assessment and certificate standard, so a training matrix built on academy certificates is consistent.
From what regulators cite, not from a syllabus
The course was not written from a syllabus. It was written from what EU regulators publish about product quality reviews that fail, then worked back to the practice that would have prevented it.
- 1Start from the deficiency category, not the regulation
- 2Find the practice that would have prevented the finding
- 3Tie that practice to its clause so it can be defended in the room
- 4Teach it on a real review, then test it
EudraGMDP non-compliance statements
Published statements of non-compliance with GMP where the PQR, the MAH's evaluation of it or the contract manufacturer arrangement is cited: late reviews, no trend evaluation, conclusions that do not follow from the data.
EMA and national competent authority inspection findings
Deficiency analyses and inspection reports published by EU national authorities, in which Chapter 1 findings on the product quality review recur every year, alongside EMA GMP/GDP Inspectors Working Group Q&As on the review and the MAH's role.
EU GMP Chapter 1, Chapter 7, Annex 15 and Annex 16
Paragraphs 1.10 and 1.11 for the review itself, Chapter 7 for the contract giver's duty to assess the acceptor's records, Annex 15 section 5 for ongoing process verification and Annex 16 for what the certifying QP relies on.
PIC/S and ICH guidance
PE 009 Chapter 1, ICH Q7 2.5, ICH Q10 3.2.4, ICH Q9 (R1) and ICH Q8 (R2), all adopted in the EU, for the expectations behind the findings.
Reviews read in consultancy and audits
Anonymised PQRs from EU and PIC/S sites, used to build the practice reviews and the weak-versus-defensible examples.
- Sources are public regulatory publications and anonymised records. The GMP Training Academy is not affiliated with or endorsed by any regulator.