EMAのGMP要求事項のリンク集

2023年12月19日 最終更新日時 : 2024年3月19日 GXP station

QMS項目	EMA
GMP	・EudraGMDP database ・Regulation No. 1252/2014 and Directive (EU) 2017/1572 For active substances and medicines for human use ・Directive 91/412/EEC and Regulation (EU) 2019/6 For medicines for veterinary use. ・Eudralex Volume 4 ・Guidance on good manufacturing practice and good distribution practice: Questions and answers
変更管理	・Classification of changes: questions and answers ・Changing the (invented) name of a centrally authorised medicine: questions and answers ・Changing the labelling and package leaflet (Article 61(3) notifications) ・Questions and answers on post approval change management protocols
当局報告	・Rapid alert notification of a quality defect / recall ・Dealing with Reports of Suspected Defective Medicinal Products
バリデーション	・Eudralex Volume 4：Annex 15 Qualification and validation ・Process validation for finished products – information and data to be provided in regulatory submissions - Scientific guideline
品質システム	・Eudralex Volume 4 ・Lifecycle management
逸脱・OOS	・Quality defects and recalls
苦情・偽薬対応	・Follow-up and non-urgent information for quality defects ・Falsified medicines: reporting obligations
品質リスクマネジメント	・ICH Q9 Quality risk management
規格及び試験方法	・Specifications and control tests on the finished product ・Control of impurities of pharmacopoeial substances ・Specifications, analytical procedures and analytical validation
不純物管理	・Impurities ・Control of impurities of pharmacopoeial substances
製造管理	・Manufacture of the finished dosage form ・Questions and answers on design-space verification ・ICH guideline Q7 for active pharmaceutical ingredients –Q&A
原料管理	・Eudralex Volume 4：Annex 8 Sampling of Starting and Packaging Materials ・Excipients in the dossier for application for marketing authorisation of a medicinal product ・Sampling and testing ・Excipients
GMP監査	N/A
無菌管理	・Eudralex Volume 4：Annex 1 Manufacture of Sterile Medicinal Products ・Maximum shelf-life for sterile products for human use after first opening or following reconstitution ・Sterilisation of the medicinal product, active substance, excipient and primary container
参考品及び保存サンプル	・Eudralex Volume 4：Annex 19 Reference and Retention Samples
CSV	・Eudralex Volume 4：Annex 11 Computerised Systems
Data Integrity	・good manufacturing practice (GMP) guidance to ensure the integrity of data
貯法・使用期限・安定性試験	・Stability ・Stability testing for applications for variations to marketing authorisation ・Stability testing of existing active ingredients and related finished products ・In-use stability testing of human medicinal products ・Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) ・Declaration of storage conditions for medicinal products particulars and active substances (Annex)
包装	・Packaging ・Changing the labelling and package leaflet (Article 61(3) notifications)
品質取決め	N/A
治験薬GMP	・Directive 2001/20/EC and Regulation (EU) 536/2014 For Investigational medicinal products ・Eudralex Volume 4：Annex 13 Manufacture of Investigational Medicinal Products
MRA(相互認証）	・Mutual recognition agreements (MRA)
その他	・Eudralex Volume 4：Annex 16 Certification by a Qualified person and Batch Release

参考情報

Part I Basic Requirements for Medicinal Products
Chapter 1	Quality Management
Chapter 2	Personnel
Chapter 3	Premise and Equipment
Chapter 4	Chapter 4 Documentation
Chapter 5	Production
Chapter 6	Quality Control
Chapter 7	on Outsourced activities
Chapter 8	Complaints and Product Recall
Chapter 9	Self Inspection

Part II Basic Requirements for Active Substances used as Starting Materials
Basic Requirements for Active Substances used as Starting Materials
Part III GMP related documents
Site Master File
Q9 Quality Risk Management (external link EMA)
Q10 Note for Guidance on Pharmaceutical Quality System (external link EMA)
MRA Batch Certificate
Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use
Annexes
Annex 1	Manufacture of Sterile Medicinal Products
Annex 2	Manufacture of Biological Medicinal Products for Human Use
Annex 3	Manufacture of RadioPharmaceuticals
Annex 4	Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 5	Manufacture of Immunological Veterinary Medicinal Products
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	Manufacture of 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	Parametric Release
Annex 19	Reference and Retention Samples
Glossary
Other documents related to GMP
Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

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