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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)

The PIC/S GMP Pipeline Part 3 of 4

The PIC/S Pipeline Part 4 of 4