03.12.2024

GMP-Compliance Adviser Update No. 5/2024

The focus of this update was on the topic of pharmaceutical water and transport of pharmaceuticals. The regulatory section contains, among other things, the new annex "questions & answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 31 May 2023".

The updated chapters are listed in the following overview:

GMP in Practice

Chapter 0 Current topics

  • 0.E The 2024 PDA/FDA Joint Regulatory Conference: A First-hand Insight

Chapter 5 Pharmaceutical water

  • 5.A Water qualities
  • 5.G Monitoring Pharmaceutical Water

Chapter 16 Storage and Transportation

  • 16.H Regulatory requirements for the transport of pharmaceuticals

GMP Regulations

Chapter B National Bodies and Pharmaceutical Associations

  • B.5 International Cooperation (MRAs)
    New annex: Questions & Answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 31 May 2023

Chapter D USA: CFR and FDA Guidelines

  • D.27 Control of Nitrosamine Impurities in Human Drugs Guidance for Industry

Chapter H WHO Guidelines

  • H.7 WHO: Good manufacturing practices for excipients used in pharmaceutical products (Technical Report Series, No.1052 (2024), Annex2)

 

To the knowledge portal

More info on the GMP Compliance Adviser


Zur Update-Übersicht