EU · EudraLex Vol 4
EU GMP 기준서 (EudraLex Vol 4)
유럽연합 의약품 GMP 기준서(EudraLex Volume 4)의 문서 목록입니다. Part I(기본 요건)·Part II(원료의약품)·Part III(보조 문서)과 부속서(Annex)를 기준서 구조 순서대로 정리했으며, 각 문서의 공식 원문 PDF로 바로 연결됩니다. 법적 효력과 최신 개정본은 반드시 공식 원문에서 확인하세요.
- Part I, Chapter 1 Pharmaceutical Quality System
- Part I, Chapter 2 Personnel
- Part I, Chapter 3 Premises and Equipment
- Part I, Chapter 4 Documentation
- Part I, Chapter 5 Production
- Part I, Chapter 6 Quality Control
- Part I, Chapter 7 Outsourced Activities
- Part I, Chapter 8 Complaints, Quality Defects and Product Recalls
- Part I, Chapter 9 Self Inspection
- Part II Basic Requirements for Active Substances Used as Starting Materials
- Part III Explanatory Notes on the Preparation of a Site Master File
- Part III, ICH Q9(R1) Quality Risk Management
- Part III, ICH Q10 Pharmaceutical Quality System
- Part III MRA Batch Certificate
- Part III Template for the Written Confirmation for Active Substances Exported to the European Union for Medicinal Products for Human Use
- Part III Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities
- Part III, 2015/C 95/02 Guidelines on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use
- Part III Template for IMP Batch Release
- Part III Guideline on the Responsibilities of the Sponsor with Regard to Handling and Shipping of Investigational Medicinal Products for Human Use in Accordance with Good Clinical Practice and Good Manufacturing Practice
- Part III Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders
- Annex 1 Manufacture of Sterile Medicinal Products
- Annex 2 Manufacture of Biological Active Substances and Medicinal Products for Human Use
- Annex 3 Manufacture of Radiopharmaceuticals
- Annex 6 Manufacture of Medicinal Gases
- Annex 7 Manufacture of Herbal Medicinal Products
- Annex 8 Sampling of Starting and Packaging Materials
- Annex 9 Manufacture of Liquids, Creams and Ointments
- Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
- Annex 11 Computerised Systems
- Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products
- Annex 13 Detailed Commission Guideline on Good Manufacturing Practice for Investigational Medicinal Products
- Annex 14 Manufacture of Products Derived from Human Blood or Human Plasma
- Annex 15 Qualification and Validation
- Annex 16 Certification by a Qualified Person and Batch Release
- Annex 17 Real Time Release Testing and Parametric Release
- Annex 19 (2005 version) Reference and Retention Samples
- Annex 19 (2026 revision) Reference and Retention Samples
- Annex 21 Importation of Medicinal Products
