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 …
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 …
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 …
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 …
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 …
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 …
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 acceptably safe.
It is the equivalent …
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 current EU GMP code and …
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 surprised when they stated that …
