GMP references
Every EU GMP chapter, annex and ICH guideline our pages and self-check refer to, with the paragraphs worth reading. Links go to the official sources. Last reviewed 15 November 2026.
- EU GMP Part I, Chapter 1: Pharmaceutical Quality System (2013)EudraLex Volume 4, Part I
What to read: §1.4 (xii)–(xiv): change evaluation, root cause · §1.10–1.11 product quality review
- EU GMP Part I, Chapter 2: Personnel (2014)EudraLex Volume 4, Part I
What to read: §2.11: training for assigned duties, effectiveness
- EU GMP Part I, Chapter 3: Premises and Equipment (2015)EudraLex Volume 4, Part I
What to read: §3.41: calibration at defined intervals
- EU GMP Part I, Chapter 4: Documentation (2011)EudraLex Volume 4, Part I
What to read: §4.3 approval and effective date · §4.5 regular review of documents · §4.8 records at the time · §4.11–4.12 retention · §4.29 required procedures
- EU GMP Part I, Chapter 6: Quality Control (2014)EudraLex Volume 4, Part I
What to read: §6.9: trend evaluation
- EU GMP Part I, Chapter 8: Complaints, Quality Defects and Recalls (2015)EudraLex Volume 4, Part I
What to read: §8.5: written complaint procedures
- EU GMP Part I, Chapter 9: Self InspectionEudraLex Volume 4, Part I
What to read: §9.1–9.3: programme, independence, records
- Annex 1: Manufacture of Sterile Medicinal Products (2022)PDF, European Commission
What to read: §4.16 pressure alarms · §9.30 Table 6 limits · §9.32–9.38 aseptic process simulation · §9.44 incubation of APS units
- Annex 11: Computerised Systems (2011)EudraLex Volume 4, Annexes
What to read: Validation, data integrity, audit trail
- Annex 15: Qualification and Validation (2015)PDF, European Commission
What to read: §4.1–4.2 periodic review, requalification · §11 change control
- Annex 16: Certification by a Qualified Person and Batch Release (2015)PDF, European Commission
What to read: Certification of each batch by a QP before release
- Annex 22: Artificial Intelligence (DRAFT, consultation 2025)EudraLex Volume 4, consultation documents
What to read: Draft only, not in force. Our summary
- ICH Q9(R1): Quality Risk Management (2023)ICH quality guidelines
What to read: Risk-based decisions on changes and deviations
What to read: §3.2.2 CAPA · §3.2.3 change management
The individual chapter PDFs are listed on the EudraLex Volume 4 page. We quote the official English texts.