PIC/S GMP Documentation Tips
What you need to know about PIC/S GMP Documentation
The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December this year means Australian GMP manufacturers need to review their …
New PIC/S GMP PE009-13
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 …
A User Requirement Specification (URS) now mandatory in Australian GMP says PIC/S 13
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 …
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 …
Quality Risk Assessment
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 …
PIC/S Version 13 is here, are you ready?
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 …
2015 MHRA GMP Inspection Deficiency Data Trends
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are …
New Revision of PIC/S GMP Guide (PIC/S PE 009-13) Now Live
On 1st of January 2017, revision 13 of the PIC/S Code of GMP for medicinal products (PIC/S PE 009-13) entered into force. Four Chapters of PIC/S PE 009-13 were revised to align with the …
Outdated Australian GMPs – Should we be doing more to protect our "brand Australia"?
As the gap between current EU/PIC/S GMPs and Australian GMPs widens, is the TGA losing relevance?
Last week, I was speaking with a respected Senior Quality Executive from a leading Australian pharmaceutical manufacturer, I was …