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 on the release of terminally sterilised medicinal products. Since then, there have been significant changes in…
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 in the process of updating its guideline on Process Validation, and there has been advancement in…
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…
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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