PIC/S version 13

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 …

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 …

pics tablets

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 …