EMA-GMP

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

EMA-GMP(Part I 製剤)

• Part I Basic Requirements for Medicinal Products
  • Chapter 1      Quality Management
  • Chapter 2      Personnel
  • Chapter 3      Premise and Equipment
  • 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

EMA-GMP(Part II 原薬)

• Part II Basic requirements for active substances used as starting materials

EMA-GMP(Part III 関連通知)

Part III GMP related documents

• 【SMF】Site Master File
• 【品質システム】Q9 Quality Risk Management
• 【品質システム】Q10 Note for Guidance on Pharmaceutical Quality System
• 【MRA】MRA Batch Certificate
• 【輸入製品】Template for the "written confirmation" for active substances exported to the European Union for medicinal products for human use (Version 2, January 2013)
• 【暴露限界】Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
• 【原料】Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use 
• 【治験薬】Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
• 【治験薬】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
• 【製造販売】Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

EMA-GMP(Annexes)

• Annex 1 【無菌医薬品】Manufacture of Sterile Medicinal Products
• Annex 2【生物学的医薬品】 Manufacture of Biological active substances and Medicinal Products for Human Use 
• Annex 3【放射性医薬品】 Manufacture of Radiopharmaceuticals
• Annex 4 【動物医薬品】Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
• Annex 5 【動物用免疫学的医薬品】Manufacture of Immunological Veterinary Medicinal Products
• Annex 6 【医療用ガス】Manufacture of Medicinal Gases
• Annex 7 【生薬】Manufacture of Herbal Medicinal Products
• Annex 8 【出発材料および包装材料のサンプリング】Sampling of Starting and Packaging Materials
• Annex 9 【液体、クリーム、軟膏の製造】Manufacture of Liquids, Creams and Ointments
• Annex 10【吸入用加圧定量噴霧式エアロゾル製剤の製造】 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
• Annex 11 【コンピューター化システム】Computerised Systems
• Annex 12【医薬品の製造における電離放射線の使用】 Use of Ionising Radiation in the Manufacture of Medicinal Products
• Annex 13 【治験薬】Manufacture of Investigational Medicinal Products
• Annex 14【ヒト血液及びヒト血漿由来医薬品の製造】 Manufacture of Products derived from Human Blood or Human Plasma 
• Annex 15【クオリフィケーション及びバリデーション】 Qualification and validation 
• Annex 16【QPによる認証及びバッチ出荷判定】 Certification by a Qualified Person and Batch Release 
• Annex 17 【パラメトリックリリース】Parametric release 
• Annex 19 【参考品及び保存サンプル】Reference and Retention Samples
• Annex 21 【医薬品の輸入】Importation of medicinal products

PICSのCMC薬事関連の通知

原薬関係

• Active substance master file procedure
• Chemistry of active substances (chemistry of new active substances)
• Investigation of chiral active substances (human)
• Summary of requirements for active substances in the quality part of the dossier

製剤関係

• Process validation for finished products – information and data to be provided in regulatory submissions
• Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form
• Pharmaceutical quality of inhalation and nasal products
• Quality of oral modified release products
• Quality of transdermal patches
• Quality and equivalence of topical products
• Radiopharmaceuticals

無菌関係

• Sterilisation of the medicinal product, active substance, excipient and prima

品質管理・安定性試験・使用期限等

• Control of impurities of pharmacopoeial substances
• Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations
• ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
• Setting specifications for related impurities in antibiotics
• Specifications and control tests on the finished product
• Declaration of storage conditions for medicinal products particulars and active substances (Annex)
• In-use stability testing of human medicinal products
• Maximum shelf-life for sterile products for human use after first opening or following reconstitution
• Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form)
• Stability testing for applications for variations to marketing authorisation
• Stability testing of existing active ingredients and related finished products

原材料管理（原料・資材）

• Quality of water for pharmaceutical use
• Plastic primary packaging materials
• Excipients in the dossier for application for marketing authorisation of a medicinal product
• Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases)

その他

• Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template"
• Quality documentation for medicinal products when used with a medical device
• Development pharmaceutics
• Pharmaceutical development of medicines for paediatric use
• Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
• Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
• Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
• Suitability of the graduation of delivery devices for liquid dosage forms
• Questions and answers on post approval change management protocols