12.07.2024
GMP Compliance Adviser Update No. 3/2024
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
- D.1.1 21 CFR Part 210
- D.1.2 21 CFR Part 211
- D.1.3 21 CFR Part 11
- D.1.4 21 CFR Part 820
- D.1.5 21 CFR Part 4
- D.1.6 21 CFR Part 600
- D.1.7 21 CFR Part 606
- D.1.8 21 CFR Part 680
- D.1.9 21 CFR Part 601
Chapter G GMP of other Regions
- G.6 Australian Regulations