17.04.2024

GMP Compliance Adviser Update No 2/2024

Focuses of this update are: Regulatory requirements for sterile manufacturing in accordance with the Annex 1, Pure steam systems and material flow, personnel flow and layout (room)


The following overview lists the topics covered with this Update:

GMP in Practice

Chapter 3 Premises

  • 3.B Material flow, personnel flow and layout

Chapter 5 Pharmaceutical Water

  • 5.F Pure steam systems

Chapter 12 Sterile Production

  • 12.A Regulatory requirements for sterile manufacturing in accordance with the new Annex 1 of the EU GMP Guidelines

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 3 has been updated)

Chapter E ICH Guidelines

  • E.3.C ICH Q3C(R9): Impurities: Guideline for Residual Solvents

Chapter G GMP of other Regions

  • G.5 Indian Regulations
  • G.6 Australian Regulations
  • G.6.4 GMP Clearance Guidance 
  • G.7 Brazilian Regulations

 

To the knowledge portal

More info on the GMP Compliance Adviser