The management review library of the GMP Training Academy
managementreview.eu 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 management 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 before your next review, a checklist the quality unit 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 against the quality system and work back to the practice that would have prevented it.
One system, not a silo
Management review sits on top of deviations, CAPA, change control, complaints, suppliers, validation and the PQR. The course teaches the connections because that is how inspectors read the records.
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 regulators and auditors record about management reviews that failed, then worked back to the practice that would have prevented the finding.
- 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 record, then test it
EU GMP Chapters 1 and 2, ICH Q10, PIC/S PE 009 and the EMA Inspectors Working Group
EU GMP 1.5, 1.6, 1.10 and 1.11 and 2.1, ICH Q10 sections 2, 3.2.4 and 4, PIC/S PE 009 Chapter 1 and the EMA GMP/GDP Inspectors Working Group Q&A for the expectations behind every finding the course teaches from.
EudraGMDP non-compliance statements and EMA inspection findings
Published non-compliance statements and inspection outcomes citing EU GMP Chapter 1: management review not effective, no evidence of senior management awareness, PQR conclusions never evaluated, and quality system deficiencies unresolved across review cycles.
National competent authority deficiency data
Annual analyses of GMP deficiencies by chapter published by EU national competent authorities. Findings against the Chapter 1 pharmaceutical quality system, senior management responsibility and PQR follow-up appear in every published year.
Inspection findings against EU GMP Chapter 1 and ICH Q10 4.1
Deficiencies raised at GMP inspections against management review: missing inputs, absent senior management, outputs with no owner, and records that show attendance rather than assessment.
Review packs and minutes reviewed in consultancy and audits
Anonymised management review records from EU sites, used to build the practice records 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.