What you need to know about PIC/S GMP Documentation Tips The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December 2017 means Australian GMP manufacturers need to review their current document retention schedules and practices to maintain compliance. PharmOut’s leading PIC/S GMP consultants have studied the new guidance and…
The New PIC/S GMP Version 13 is finally here and it’s all about the people! I have a specific interest in what is in the new PIC/S GMP, for example, Chapter 2 (Personnel), it expands and specifies the responsibilities of all personnel. Let’s look at the New PIC/S GMP together. The introduction to new PIC/S GMP…
Old news I know, and you probably always have done it this way, but did you know with the January 2018 adoption of PIC/S PE009-13 by the TGA, a User Requirement Specification (URS) is now mandatory? Annex 15, §3.1 and 3.2 state that a User Requirement Specification should be a point of reference in the…
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…
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