EU GMP: Nine Chapters, the Annexes, and the Qualified Person
EU GMP is law plus a detailed guide. Know which chapter or annex applies, check its date, and keep the qualified person's decision clear.
In Short
- Binding through Directive (EU) 2017/1572.
- Nine Part I chapters, each with its own date.
- The qualified person certifies each batch.
The Pharmaceutical Operations Guide
Right material. Right record. Released by a person.
- Who decides, and who may not
- Supplier to finished bulk
- Test, review, investigate
- Packs, serialisation and recall
Plus Evidence map and four worksheets.
Get the pharmaceutical guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Pharmaceutical Operations Guide
Right material. Right record. Released by a person.
EU GMP for human medicines rests on binding law (Directive (EU) 2017/1572) and the detailed guidelines in EudraLex Volume 4. The European Commission page lists the current chapters and annexes with their dates. This guide maps what each part covers and who decides. Sources were checked on 2 Oct 2026.
Law and Guidelines
Directive (EU) 2017/1572 sets the GMP principles for human medicines. EudraLex Volume 4 interprets them: Part I for medicinal products, Part II for active substances, Part III for related documents and a set of annexes for specific activities.
Part I in Nine Chapters
Chapter 1 pharmaceutical quality system, 2 personnel, 3 premises and equipment, 4 documentation, 5 production, 6 quality control, 7 outsourced activities, 8 complaints and product recall, 9 self inspection. Each has its own date on the Commission page.
EU GMP Part I at a Glance
| Chapter | Topic |
|---|---|
| 1 | Pharmaceutical quality system |
| 2 | Personnel |
| 3 | Premises and equipment |
| 4 | Documentation |
| 5 | Production |
| 6 | Quality control |
| 7 | Outsourced activities |
| 8 | Complaints and product recall |
| 9 | Self inspection |
- 1
- Topic
- Pharmaceutical quality system
- 2
- Topic
- Personnel
- 3
- Topic
- Premises and equipment
- 4
- Topic
- Documentation
- 5
- Topic
- Production
- 6
- Topic
- Quality control
- 7
- Topic
- Outsourced activities
- 8
- Topic
- Complaints and product recall
- 9
- Topic
- Self inspection
Quality control and results out of specification
Chapter 6 covers sampling, testing, records and the investigation of out-of-specification results and trends. Investigations are documented and the outcome feeds batch decisions and CAPA.
Worked Example: an Out-of-Specification Result
- Day 0Dissolution result for batch B-7712 below specificationAnalyst
- Day 0Lab investigation: method, equipment and calculations checkedLab supervisor
- Day 2No lab error found; full investigation opened, batch on holdQA
- Day 9Qualified person records the batch decision and rationaleQualified person
Annexes that change often
Check dates before quoting an annex. The Commission page lists a revised Reference and Retention Samples annex applicable from 24 Sep 2026, and Annex 15 on qualification and validation in operation since 1 Oct 2015.
Where V5 fits
V5 keeps controlled documents, training, batch records, laboratory results with an out-of-specification workflow, deviations, CAPA, change control, complaints, recalls and electronic signatures. The qualified person certifies batches; V5 records the evidence.
Questions
Is EudraLex Volume 4 legally binding?
The GMP principles are binding through Directive (EU) 2017/1572 and national law. Volume 4 is the detailed guideline used to interpret them, and inspectors apply it.
How many chapters does EU GMP Part I have?
Nine, from pharmaceutical quality system to self inspection, each with its own date on the European Commission page.
Who certifies a batch under EU GMP?
The qualified person named on the manufacturing authorisation.
Does V5 certify or release batches?
No. V5 records batch, laboratory and quality evidence with electronic signatures. The qualified person makes the certification decision.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global Pharmaceutical GMP Readiness: Principles That Travel
Australia Pharmaceutical GMP Readiness: TGA and PIC/S GMP
Brazil Pharmaceutical GMP Readiness: ANVISA RDC 658/2022
Canada Drug GMP Readiness: Food and Drug Regulations Part C, Division 2
China Pharmaceutical GMP Readiness: NMPA and China GMP
GCC Pharmaceutical GMP Readiness: Saudi SFDA and UAE