Medsafe has announced its intention to adopt version 13 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13).
Since 01 January 2018 the TGA has adopted PIC/S Guide to GMP version 13 (PE 009-13), excluding Annexes 4, 5 and 14, as the manufacturing principles for:
- medicines and active pharmaceutical ingredients
- biologicals that comprise or contain live animal cells, tissues or organs
For GMP-licensed pharmaceutical manufacturing organisations, this represents a major change with the guide advancing significantly in 5 versions over 8 years; from version 8 (January 2009) to version 13 (January 2017). In addition, 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 GMP inspections of manufacturers.
Compliance with PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) requires a company-wide Pharmaceutical Quality System (PQS)* across the entire product life cycle. There is a clear need for more cross-functional collaboration and improvements in data management and data integrity.
*A management system to direct and control a pharmaceutical company with regard to quality. (ICH Q10 based upon ISO 9000:2005).
Adoption of PIC/S GMP Guide version 13 by the regulators 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.
There have been a number of incremental changes to the PIC/S GMP Guide in the last 5 versions, 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 principles 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 version 8 to version 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.
Participants will come away with an understanding of:
- Why the latest PE 009-13 PIC/S Guide to GMP is so significant
- How Version 8 and Version 13 are aligned and different
- What it means for your organisation to have a Pharmaceutical Quality System
- What tools will make the transition to Version 13 easier
The course will focus on:
- Chapter 1 – Pharmaceutical Quality Systems
- Chapter 2 – Personnel
- Chapter 4 – Documentation
- Chapter 6 – Quality Control
- Chapter 7 – Outsourced Activities
- Annex 11 – Computerised Systems
- Annex 15 – Qualification and Validation
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.
Fee and Discount
- The standard fee (exc. GST) is AUD 700 per participant
- A 7.5% discount applies for 3 or more participants from the same company
Option 1 – Register and pay online by credit card through our TryBooking site following the link (where available) in the table below. A processing fee of 30c per person applies.
Option 2 – Register by e-mail following the link (where available) in the table below and pay by invoice
|Location||Date||Online by CC||Email & Invoice|
|Melbourne||15 May 2018||Register||Register|
|Brisbane||22 May 2018||Register|
|Auckland||23 May 2018||Register|
|Sydney||25 May 2018||Register||Register|
|Perth||21 June 2018||Register|
Scheduled sessions run from 9am to 5pm unless otherwise specified.
Call us or click here to e-mail us and register your interest in a public session in an alternative city or having this course delivered on-site.