Question Regarding PIC/S PE009-14

The current GMPs in Australia adhere to the PIC/S Guide to Good Manufacturing Practice, (PE009-13). This guide was adopted by the TGA in 2018 and the TGA has “just given” notice that it intends to adopt the current version of the PIC/S Guide (PE009-14) by July 1st 2020.

The Question posed on LinkedIn:

I have read PIC/S guidelines, when I was working in Pharmaceutical company. Currently, I am not working in Pharmaceutical company. I would like to keep my knowledge updated about what’s new in regulatory guidelines in Pharmaceutical. Would you please let me know, where can I get copy of new PIC/S??

My reply was this:

Hi NIta.

PIC/S makes their doccos available to anyone. Here’s the link for you:

Kind Regards


I am happy I saw the notification as now I am off to read PE009-13 and compare it to PE009-14.