Current PIC/S GMP Guides – Part 2 of 4
Current PIC/S GMP Guides
On January 15, 2009 the PIC/S The Pharmaceutical Inspection Cooperation Scheme – PIC/S released its ‘PE009-8’ Guide to GMP document. This is the current code of GMP relevant to Australia’s Therapeutic Goods Administration TGA – Therapeutic Goods Administration and medicinal product manufacturers. This document saw several significant changes, including;
Revised Annex 1 Manufacture of Sterile Medicinal Products
- This Annex is aligned with the requirements of the ISO 14644 (ISO)range of Standards, Cleanrooms and associated controlled environments
- The more stringent requirements for manufacturers of sterile vials and the need to cap vials in class A environments
- Media simulations and the allowable growth limits
- Bioburden monitoring
Revised Chapter 1
- Inclusion of clauses 1.5 and 1.6 regarding Quality Risk Management
New Annex 20
- The incorporation of ICH Q9 Quality Risk Management
Related blogs:
Past, Present and Future PIC/S GMP Part 1 of 4
Current PIC/S GMP Guides – Part 2 of 4 (this blog)
