Part I Chapter 2: Personnel
European Commission
Owner-supplied evaluation copy · 2014-03_chapter_2.pdf · 6 pages
Part I Chapter 8: Complaints, Quality Defects and Product Recalls
European Commission
Owner-supplied evaluation copy · 2014-08_gmp_chap8.pdf · 6 pages
Part II: Basic Requirements for Active Substances used as Starting Materials
European Commission
Owner-supplied evaluation copy · 2014-08_gmp_part1.pdf · 49 pages
Part I Chapter 6: Quality Control
European Commission
Owner-supplied evaluation copy · 2014-11_vol4_chapter_6.pdf · 8 pages
Annex 15: Qualification and Validation
European Commission
Owner-supplied evaluation copy · 2015-10_annex15.pdf · 16 pages
Part IV: GMP Guidelines for Advanced Therapy Medicinal Products
European Commission
Owner-supplied evaluation copy · 2017_11_22_guidelines_gmp_for_atmps.pdf · 90 pages
Annex 2: Manufacture of Biological Active Substances and Medicinal Products
European Commission
Owner-supplied evaluation copy · 2018_annex2_en.pdf · 25 pages
Annex 1 - Manufacture of Sterile Medicinal Products
European Commission
22 August 2022 · 59 pages
Annex 11: Computerised Systems
European Commission
Owner-supplied evaluation copy · annex11_01-2011_en.pdf · 5 pages
Annex 14: Medicinal Products Derived from Human Blood or Plasma
European Commission
Owner-supplied evaluation copy · annex14_rev30-03_2011_en.pdf · 13 pages
Annex 8: Sampling of Starting and Packaging Materials
European Commission
Owner-supplied evaluation copy · anx08_en.pdf · 2 pages
Annex 9: Manufacture of Liquids, Creams and Ointments
European Commission
Owner-supplied evaluation copy · anx09_en.pdf · 1 pages
Annex 10: Pressurised Metered Dose Aerosol Preparations
European Commission
Owner-supplied evaluation copy · anx10_en.pdf · 2 pages
Annex 12: Use of Ionising Radiation
European Commission
Owner-supplied evaluation copy · anx12_en.pdf · 6 pages
Revised Annex 19: Reference and Retention Samples (future-effective evaluation copy)
European Commission
Future-effective evaluation copy · applicable 24 September 2026 · 6 pages
Part I Chapter 9: Self Inspection
European Commission
Owner-supplied evaluation copy · cap9_en.pdf · 1 pages
Part I Chapter 4: Documentation
European Commission
Owner-supplied evaluation copy · chapter4_01-2011_en.pdf · 9 pages
Part I Chapter 3: Premises and Equipment
European Commission
Owner-supplied evaluation copy · chapter_3.pdf · 5 pages
Part I Chapter 5: Production
European Commission
Owner-supplied evaluation copy · chapter_5.pdf · 12 pages
Annex 13: Investigational Medicinal Products
European Commission
Owner-supplied evaluation copy · guideline_adopted_1_en_act_part1_v3.pdf · 17 pages
ICH Q10: Pharmaceutical Quality System
European Commission
Owner-supplied evaluation copy · ICH Q10 Pharmaceutical Quality System, Step 5 · 20 pages
ICH Q9(R1): Quality Risk Management
European Commission
Owner-supplied evaluation copy · mp_ich_q9guideline-ra_en.pdf · 27 pages
Annex 16: Certification by a Qualified Person and Batch Release
European Commission
Owner-supplied evaluation copy · v4_an16_201510_en.pdf · 12 pages
Part I Chapter 1: Pharmaceutical Quality System
European Commission
Owner-supplied evaluation copy · vol4-chap1_2013-01_en.pdf · 8 pages
Part I Chapter 7: Outsourced Activities
European Commission
Owner-supplied evaluation copy · vol4-chap7_2012-06_en.pdf · 4 pages
Annex 7: Manufacture of Herbal Medicinal Products
European Commission
Owner-supplied evaluation copy · vol4_an7_2008_09_en.pdf · 6 pages
Annex 21: Importation of Medicinal Products
European Commission
Owner-supplied evaluation copy · vol4_annex21_en.pdf · 6 pages