New PIC/S GMP version 13 The TGA finally formally announced adoption of the new PIC/S GMP version 13 (PE009-13, 1 January 2017) which is scheduled to commence on 31 December 2017! In this public statement the TGA announced: from 1st January 2018, the TGA GMP inspectors will use the new GMP Guide during inspections. Compliance with the…
In Australia, a Quality Risk Assessment is now a regular GMP activity since we saw the introduction of PIC/S Version PE 009-08, in 2009 (read more here) and the massive impact, especially of the two new clauses §1.5 and §1.6 (Part 1 of the PIC/S GMP) had on the Australian industry, as we followed the USFDA…
In early 2017, the United States Pharmacopeial Convention (USP), European Medicines Agency and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) finalised guidelines (ICH Q3D and USP ) containing new permitted daily exposure limits for elemental (inorganic) impurities in pharmaceuticals and dietary supplements. On the 17th of August 2015,…
Yes, we are still talking about the very old issue of Good Manufacturing Practice Pens or GMP pens and the most suitable colour of ink for pharmaceutical manufacturing pens and other issues. The various codes simply refer to “indelible ink”, as snipped from PIC/S Version 13 Good Manufacturing Practices, §4.7 Good Documentation Practices 4.7 Handwritten…
For Australian and New Zealand Manufacturers PIC/S Version 13 is due this year, aside from significant changes in Part 1, there are also significant changes in Annex 11, Computers Systems and Annex 15, Qualification and Validation. We plan to help you get ready now for the pending change. Following on from the highly successful PIC/S…
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