12.02.2025

GMP-Compliance Adviser Update No. 1/2025

The updated chapters are listed in the following overview:

GMP in Practice

Chapter 1 Quality Management Systems

1.C Quality assurance duties

GMP Regulations

Chapter C EU Directives and Guidelines

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 – Appendix 1

Chapter F PIC/S Guidelines

To the knowledge portal

More info on the GMP Compliance Adviser

Zur Update-Übersicht