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 remains, the codification of Quality …
The PIC/S meeting in Kiev discussed and agreed on changes to PE009-9 to support the harmonisation of GMP guidance documents. PIC/S code of GMP PE-009-10 was issued by PIC/S on the 11th December, and whilst this goes some way …
This concept paper addresses the need to update Annex 17 (Parametric release) of the EU GMP Guide. At the time the original guideline was adopted (January 2002), the main foreseen application area was sterility testing, with a particular focus …
Annex 15 qualification and validation was originally published in September 2001, and since then there have been significant changes in the GMP environment with the incorporation of ICH Q9 and Q10. In addition, the Quality Working Party (QWP) is …
The PIC/S pipeline
This article is part of a historical series of discussions relating to PIC/S GMP changes (2011).
Continuing on from our last post, the following changes are happening or have happened to the PIC/S GMPs:
Annex 2 Biological Medicinal Products …
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 Practices for Medicinal Products Manufacturers held …
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 …
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, traced through the history, current …
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 PIC/S website, the mission of …
