GMP Compliance Adviser Update No. 2/2024

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

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