Chapter 7 “Contract Manufacture and Analysis” will be re-titled as “Outsourced Activities” from the 31st of January 2013. The revision will provide further clarification and guidance on “any activity covered by the GMP guide that is outsourced”, rather than just “contract manufacture and analysis”, as per the previous version. This update also aligns the context…
History of TGA & Medsafe ‘Early Warning System’ project discussions One of the projects identified by the TGA and Medsafe when they formed ANZTPA in 2011, was to develop an early warning system to assist in the communication of potential safety issues with therapeutic products. This article provides a historical overview of the efforts of…
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 has progressed through the public consultation phase. Annex 11 Computerised Systems has now…
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 in January 2011. One session, conducted by the HSA’s Boon Meow Hoe traced the history, current…
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…
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 applicability and future trends of PIC/S GMP. PIC/S History PIC/S has been at the forefront…
HISTORY of Chinese GMP guidelines Updated GMP guidelines were issued by the Chinese SFDA in February 2011, and went into force starting March 1st, 2011. This blog discusses historical changes in Chinese GMP guidelines and includes links to articles from the World Health Organisation (WHO). Chinese GMP updates from 2011 Chinese GMP vs the EU…
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 the PIC/S organisation is ” “to lead the international development, implementation and maintenance of…
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