PIC/S version 13

PIC/S GMP Documentation Tips

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 …

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 …

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 …