ExpiredPIC/S PE 009-13 GMP

PIC/S PE 009-13 GMP

This full day course will be facilitated by Trevor Schoerie and Maria Mylonas, Australia leading GMP consultants:

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.

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 PE009 GMP - Masterclass (MEL-13-10-17)
    13 October 2017
    9:00 am - 4:00 pm

Location

Venue:  

Venue Phone: +61 3 9485 1000

Venue Website:

Address:
215 Bell Street, Preston, Victoria, 3072, Australia

Description:
Bell City is based in the heart of Melbourne’s vibrant inner north, just 20 minutes from Melbourne Airport and the CBD. Whether you’re travelling in style or on a budget, looking for a new place to call home or an ideal space to hold an event, conference or wedding, you’ll find everything you need at Bell City.