Adelaide PIC/S PE009 GMP – $13.00
The PIC/S Code of GMP for the manufacture of medicinal products PE 009 version 13 which came into effect in January 2017 we re offering a 1 day training course covering the essential “what you need to know“.
New PIC/S GMP version 13
The TGA finally formally announced adoption of the latest PIC/S GMP Guide 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 TGA GMP inspectors will use the new GMP Guide during inspections.
Compliance with the requirements of the latest PIC/S GMP Guide (PE009-13, 1 January 2017) will be expected from this adoption date; however, inspectors will take a pragmatic approach to discussing and reporting and we are seeing them already reporting deficiencies.
A 12 month, graduated transition period will be provided to allow manufacturers time to assess the new supplementary requirements contained in the new Manufacturing Principles and implement changes to procedures and practices to fully comply with the new guide.
Full compliance with the PIC/S Guide to GMP (PE009-13, 1 January 2017) will be expected after this 12 month transition period ends, 1st January 2019!
Read more here on the PIC/S version 13 GMP training.
- PIC/S GMPs (ADE-18-10-17)
18 October 2017
9:00 am - 4:00 pm
Venue: The Lion Hotel - Adelaide