The TGA announced on 13 September 2017 that it will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens from 31 December 2017.
Since 2010, the TGA has enforced PIC/S Guide to GMP version 8 (PE 009-8), issued 15 January 2009 (excluding Annexes 4, 5 and 14).
From 31 December 2017, TGA GMP inspections will reference PIC/S Guide to GMP version 13 (PE 009-13), issued 1 January 2017, and compliance will be expected from 31 December 2017 with a 12 month transition period to full compliance.
The TGA is encouraging manufacturers to ensure they are familiar with the main changes and requirements of PIC/S GMP Guide PE 009-13 relevant to their manufacturing operations and to commence preparations for compliance with this new regulation. With significant changes to be implemented in one leap, jumping 5 versions (over 8 years), you can rely on SeerPharma to support your organisation with this critical challenge.
SeerPharma has developed a 1-day training course to help you understand the new requirements and build capability across your organisation in key areas such as management responsibility, product realisation, continual improvement, knowledge management, outsourced activities, validation and change management.
A number of companies attended public sessions of this course in June 2017, while others have
requested that we deliver this course on site. To further support the industry, SeerPharma has developed a 5-day Intensive Workshop to assist organisations with the impending change.
Contact us if you’d like assistance with the change to version 13 of the PIC/S GMP Guide, whether it be a short course, 5-day workshop, or ongoing consulting assistance.
This post was adapted from our July 2017 Journal. You may also be interested in:
