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
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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More info on the GMP Compliance Adviser