PIC/S

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Update from PIC/S Meeting in Geneva

The PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Sub-Committee on Training Meeting took place in Geneva between 28-30 May 2013. The main topics that were discussed are summarized below.

A new Sub-Committee structure …

Useful Tips for Quality Risk Management Implementation

On 29 July 2009, Australia’s Therapeutic Goods Administration (TGA) adopted the PIC/S Guide to Good Manufacturing Practice PE009-8.

One of the single biggest changes from the previous Australian Code of Good Manufacturing Practice was, and …

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The PIC/S Pipeline Part 4 of 4

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 has now …

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The PIC/S GMP Pipeline Part 3 of 4

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

One session, conducted by the HSA’s …

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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, …

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Why PIC/S compliance is so important

With the US FDA joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S),  compliance with the PIC/S GMP standards should be a priority for any pharmaceutical manufacturer exporting to multiple countries.
What is PIC/S?

As described on the …