The change control library of the GMP Training Academy
changecontrolgmp.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 change control 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 tomorrow's change review, a checklist QA 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 change management and work back to the practice that would have prevented it.
One system, not a silo
Changes feed validation, regulatory submissions, quality agreements, the PQR and management review, and deviations feed changes. 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 change control, deviation management, 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 publish about what goes wrong with change control, 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 record, then test it
EudraGMDP non-compliance statements
Statements of non-compliance with GMP published by EU national competent authorities, where uncontrolled changes, loss of the validated state and dossier mismatches are cited, most often for changes made before assessment.
National competent authority inspection findings
Published deficiency trends and annual inspection reports from EU national authorities. Change control, qualification and validation under Annex 15 and Chapter 1 recur in the top categories, typically for changes to procedures, equipment and computerised systems made without assessment and approval by QA.
EMA GMP/GDP Inspectors Working Group and PIC/S publications
EMA Q&As on change management, the validated state and outsourced activities, and PIC/S guidance including PI 041-1 on data integrity for computerised system changes.
EU GMP Annex 15, Annex 11, ICH Q9 (R1) and ICH Q10
The expectations behind the findings: what a change record must contain, how risk should drive the assessment, and the regulatory question ICH Q10 3.2.3 requires.
Site change records reviewed in consultancy and audits
Anonymised change controls, 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.