A User Requirement Specification (URS) now mandatory in Australian GMP says PIC/S v13
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A User Requirement Specification (URS) now mandatory in Australian GMP says PIC/S v13

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…

Australia finally adopts new PIC/S GMP version 13 – comes into force 31st December 2017
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Australia finally adopts new PIC/S GMP version 13 – comes into force 31st December 2017

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…