12.07.2024

GMP Compliance Adviser Update No. 3/2024

This update focuses on the topics of sterile production, airlock concepts and materials in the practice section of the GMP Compliance Adviser.
Regulatory changes include the Appendix 1 of the Q&A on nitrosamine impurities of the EMA, the Australian GMP guidelines and the 21 CFRs of the US FDA.


The updated chapters are listed in the following overview:

GMP in Practice

Chapter 3 Premises

  • 3.C Airlock concepts

Chapter 4 Facilities and Equipment

  • 4.B Materials

Chapter 12 Sterile Production

  • 12.D Sterilisation processes

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 D USA: CFR and FDA Guidelines

Chapter G GMP of other regions

  • G.6 Australian Regulations

 

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