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The PIC/S Pipeline Part 4 of 4

The PIC/S pipeline
Continuing on from our last post, the following changes are happening or have happened to the PIC/S GMPs:

Annex 2 Biological Medicinal Products has progressed through the public consultation phase.

Annex 11 Computerised Systems …

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The PIC/S GMP Pipeline Part 3 of 4

In trying to work out what is in the PIC/S GMP Pipeline we examined the Health Products Regulation Group (HPRG) of Singapore’s Health Sciences Authority (HSA ) held a regulatory workshop on Good Manufacturing …

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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 …

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Past, Present and Future PIC/S GMP Part 1 of 4

In January of 2011, the Health Products Regulation Group (HPRG) Health Sciences Authority (HSA) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers.

One session, conducted by the HSA’s Boon Meow Hoe, …

New Chinese GMP

New GMP guidelines were issued by the Chinese SFDA in Feb. 2011 and will come into force starting from March 1st 2011.

The requirements of the new revision are very similar to the EU GMPs and …