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
Chapter 4 Facilities and Equipment
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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More info on the GMP Compliance Adviser