GMP-Compliance Adviser Update No. 4/2024

GMP in Practice

Chapter 3 Premises

• 3.G Safety cabinets

Chapter 12 Sterile Production

• 12.E Aseptic processing
• 12.F Sterility testing

GMP Regulations

Chapter B National Bodies and Pharmaceutical Associations

• B.2 Government Authorities in Europe
• B.5 International Cooperation (MRAs)

Chapter C EU Directive and Guidelines

• C.3.2 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials
  Extra: GMP for APIs: “How to do” Document, Version 16
• C.7 Compilation of Union Procedures on Inspections and Exchange of Information
• C.19 Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Chapter G GMP of other Regions

• G.3.3 MHLW Ministerial Ordinance No. 179, 2004: Standard of Manufacturing Control and Quality Control for Pharmaceuticals and Quasi-Pharmaceuticals

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