The TGA's transitional period to version 13 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) is over. Compliance with PIC/S GMP Guide PE 009-13 (excluding Annexes 4, 5 and 14) has been mandatory since 1 January 2019 for:
- medicines and active pharmaceutical ingredients
- biologicals that comprise or contain live animal cells, tissues or organs
Medsafe is also expected to adopt a newer version of the PIC/S GMP Guide shortly.
GMP-licensed pharmaceutical manufacturing organisations need to have implemented major changes with the GMPs 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).
The required full implementation of GMPs in accordance with PIC/S GMP Guide PE 009-13 by regulators will test some companies’ ability to respond in a coordinated, cost-efficient and timely way.
This training course is designed to help you understand the 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 are a number of incremental changes to the PIC/S Guide to GMP between version 8 and version 13, as shown in this revision history snapshot:
|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.
Participants will come away with an understanding of:
- Why the 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 required full implementation of 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 changes 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 in a public session or having this course delivered on-site.