The TGA has signalled adoption of the latest PIC/S Guide to GMP Guide in 2017 and licensed pharmaceutical manufacturers should be anticipating this major change from PE 009-8 (January 2009) to PE 009-13 (January 2017). More recently and in support of this, the TGA has announced that as a PIC/S member, it intends to reference the PIC/S Good Practices for Data Management and Integrity In Regulated GMP/GDP Environments, PI 041-1 (Draft 2) when performing inspections of manufacturers.
Compliance with the latest PIC/S Guide to GMP requires a company-wide Quality Management System* across the entire product life cycle. There is a clear need for more cross-functional collaboration and improvements in data management and data integrity. Adopting the latest PIC/S GMP Guide version 13 as the Australian Code of GMP will test some companies’ ability to respond in a coordinated, cost-efficient, and timely way.
SeerPharma is providing this 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.
* Pharmaceutical Quality System: A management system to direct and control a pharmaceutical company with regard to quality. (ICH Q10 based upon ISO 9000:2005).
There have been a number of incremental changes to the PIC/S GMP Guide since PE 009-8, as shown in the revision history:
|Date||Version Number||Reasons for Revision|
|15 January 2009||PE 009-8||Revision of Chapter 1 (Part I)
Revision of Annex 1
New Annex 20
|1 September 2009||PE 009-9||Revision of Annex 3|
|1 January 2013||PE 009-10||Revision of Chapter 4 (Part I)
Revision of Annex 6, 7, 11 and 13
|1 March 2014||PE 009-11||Introduction of QRM principals in PIC/S GMP Guide – Part II
Revision of Annex 2 and 14
|1 October 2015||PE 009-12||Revision of Annex 15|
|1 January 2017||PE 009-13||Revision of Chapters 1, 2, 6 & 7 (Part I)|
Organisations face a critical challenge in jumping all the way from PE 009-8 to PE 009-13 in one leap to incorporate so many revisions and a serious shift in approach. As such, pharmaceutical manufacturers will need to implement considerable changes to maintain GMP compliance.
This training will provide you with an understanding of the changes and differences between PIC/S GMP Guide versions PE 009-8 and PE 009-13 and what it means for your company. Key focus points for the program are:
- How does version 13 align with the TGA’s current Code of GMP (version 8)?
- What hasn’t changed?
- What has changed and why is it so significant?
This course has been designed for senior staff in all areas in pharmaceutical manufacturing organisations to understand how the anticipated changes will affect their business unit as well as their business unit’s interactions with other units and the shifts in responsibilities.
You may be a Production Manager, QA Manager, QA Supervisor, QC Manager, IT Manager, Contract Manager, Validation Manager etc.
Format and Course Length:
The 1-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Call us or click here to e-mail us and register your interest.