GMP Compliance Adviser Update No. 1/2024

GMP in Practice

Chapter 3 Premises

• 3.F Barrier systems (RABS and isolators) for sterile manufacturing

Chapter 12 Sterile Production

• 12.C Manufacture of terminally sterilised products

GMP Regulations

Chapter C EU Directives and Guidelines

• C.7 Compilation of Union Procedures on Inspections and Exchange of Information
• 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

Chapter E ICH Guidelines

• E.2 ICH Q2(R2) Validation of Analytical Procedures
• E.5.A ICH Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
• E.14 ICH Q14 Analytical Procedure Development

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