New PIC/S GMP version 13
The TGA finally formally announced adoption of the new PIC/S GMP 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 new 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.
A 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!
What this means for us?
Well in short: a lot of work! Not only have there been significant changes in Part 1 but significant changes in the Annexes, namely, Annex 11 and Annex 15, which are substantially different.
How we can help
We cannot personally help every manufacturer, so we started our journey to get ourselves and the Australian Pharmaceutical Industry ready earlier this year on Friday the 13th January 2017. With a series of PIC/S training courses around the country in January / February, we again dropped into more detail during the National GMP and Validation forum, and starting on Friday the 13th October we are running a PIC/S Version 13 Part 1 training for $13 in Australia, yes only $13!
Bookings are running out fast so please book early.
More courses are scheduled for around the country for just $13 per person per day –
Not sure if you should attend, here is a quick overview of the latest changes.
Request our free new PIC/S GMP gap analysis tool and SOP
Please contact us if you would like our line by line Excel gap analysis tool, as part of your SOP to Manage Changing GMPs.
We will be offering full price training on Annex 11 and Annex 15.
Read more about the TGA Announcement
Since the release of PIC/S version 8, there have been a number of incremental changes, 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||Revision of Annex 1||Revision of Annex 1|
|New Annex 20 (Quality Risk Management)||New Annex 20 (Quality Risk Management)||New Annex 20 (Quality Risk Management)|
|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||Revision of Annex 6, 7, 11 and 13||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||Revision of Annex 2 and 14||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)|
How is PharmOut helping?
Regulated companies face a critical challenge ahead in leaping from PE 009-8 to PE 009-13, pharmaceutical manufacturers and other regulated companies will need to implement considerable changes to maintain GMP compliance.
Obviously, we are very happy to help you to recover from a bad TGA GMP Inspection, but its is much better not to be on the TGA naughty list in the first place. We hope that this training offer will help you avoid the need for any GMP “enhancement” programs, after all, a high level of GMP compliance should manifest in better quality products.
If you choose to attend one of these training courses participants will have a fun day, yes we have made it fun and you should come away energised with an understanding and action plan of how to tackle this new guidance, specifically:
- Why the new PIC/S GMP PE 009-13, the new PIC/S Guide to GMP is so significant,
- Common pitfalls, so where are the Europeans struggling,
- How Version 8 and Version 13 are aligned and different,
- What it means for your organisation to have a Pharmaceutical Quality System,
- Free procedures, gap analysis and tracking tools that should make the transition to Version 13 easier.
Who or what is PIC/S?
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly known as PIC/S) develop international GMP standards between countries and pharmaceutical inspection authorities, to provide a harmonised and constructive co-operation in the field of Good Manufacturing Practice. In short to ensure best regulatory practice and equivalence or a level playing field but more importantly, to ensure the safety and efficacy of the pharmaceutical drugs we and our relatives consume.
The PIC/S provide an active and constructive cooperation in the field of GMP and related areas. The purpose of PIC/S is to facilitate:
- networking between participating authorities
- maintenance of mutual confidence
- exchange of information and experience
- mutual training of GMP inspectors.
The TGA, (and not Australia) is an active member of the PIC/S and PIC/S works differently to an Mutual Recognition Agreement (MRA).
How this becomes Australian law?
Section 36 of the Therapeutic Goods Act 1989 allows the Minister for Health to determine Manufacturing Principles that are to be applied in the manufacture of therapeutic goods.
Currently the Therapeutic Goods (Manufacturing Principles) Determination No 1 (2013) specifies that medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice (GMP) – 15 January 2009, PE 009-8, except for its Annexes 4, 5 and 14 which are not adopted by Australia.
Through the operation of section 36 and other provisions within the Act, the PIC/S Guide to GMP has legal force in Australia. So the new PIC/S GMP is not yet law.Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.