Practical Approaches to Data Integrity, 03 Dec 2018
The ISPE Australasia Affiliate hosted a 1 day Data Intergrity seminar in Sydney on 3rd Dec 2018. The day was led by one of our Australian Affiliate members, Charlie Wakeham, Waters Asia who has been instrumental in developing the recently (or soon to be) published ISPE GAMP Good Practice Guides - Data Integrity Key Concepts and Data Integrity for Manufacturing Systems.
Charlie provided a comprehensive overview of the guides in a fun and interactive manner. Each session was finished with a well thought out workshop, providing a hands on practical demonstration of the critical thinking associated with developing Data Integrity programs within an organisation.
We will be holding a reprise of this seminar in March 2019 in New Zealand for those who missed out.
Advanced Sterile Facilities and Design, 19-20 November 2018
The ISPE Australasia Affiliate collaborated with the Australian Chapter of PDA to bring an informative sterile seminar to Melbourne. The event was held at the Novotel on Collins over two days with Norman Goldschmidt, Genesis Engineers Inc. presenting.
Norm's presenting style was exceptional and he managed to keep the room engaged whilst navigating his way through topics from Regulatory Expectations, Cleanroom Design, Qualification and Optimisation, Cross-contamination Prevention and Advances in Aseptic Processing Technologies.
Our thanks go out to our 7 sponsor companies who provided support for the event and were present to show some of the new and existing services available within the Australian sterile manufacturing environment.
The overall feedback was excellent and some great discussion was held amongst the delegates. The TGA were present at the wrap up for both days, and with a well attended networking session held after the first day the opportunity for networking was great.
The seminar really drove home the importance of face to face meeting with industry peers as a means to share and transfer knowledge for our ultimate joint goal of providing Product Quality and Safety for Patients.
Thank you to our sponsors who helped to make the seminar a success:-
Inaugural TGA GMP Forum, 26 June 2018
The ISPE Australasia Affiliate were delighted and honoured to be invited by the Australian Regulator, the Therapeutic Goods Administration (TGA), to participate in the organisation of the Inaugural TGA GMP Forum on 26th June 2018, in conjunction with three other pharmaceutical industry associations PDA, RACI and ARCS.
Benjamin Sauer, ISPE Australasia President and Helen Atkinson, ISPE Australasia Vice President formed part of the 12 person organising committee made up from members of each association and the Manufacturing Quality Branch (MQB) of the TGA. The committee were asked to provide guidance on content to be delivered by the TGA, and recommendations related to organisation and promotion of the event.
The event was a huge success with the registration closing 3 weeks early as we reached the maximum capacity of our venue at 450 delegates.
The 2018 GMP Forum was opened with an introductory session from Ben Noyen, Assistant Secretary, TGA MQB and Adjunct professor John Skerritt – Deputy Secretary, TGA Health Products Regulation Group, providing open and transparent communication on the TGA processes, fees and charges.
Following this, Jenny Hantzinikolas – Director, Inspections Section (IS), TGA MQB provided an overview of the TGAs participation in the Global GMP forums and committees, highlighting the important role that Australia plays in shaping the worldwide regulations for GMP. In particular the TGA have key roles in the Pharmaceutical Inspection Cooperation Schemes (PIC/S) which reviews, writes and recommends the Code of GMP adopted by many of the Asia Pacific regions. A key message from this session was that the TGA encourage industry feedback related to all areas of GMP, and the mechanisms for feedback were discussed and highlighted.
Stephen Farrell – Assistant Director, Licensing & Certification Section (LCS), TGA MQB discussed some of the changes and improvements made to the overseas GMP Clearance process, and highlighted some of the challenges faced in the current regulatory circumstances as other regulators are starting to also accept desk based certifications.
The day continued with TGA presenters from the MQB Inspections Section and the Licensing and Certifications Section providing updates on a variety of GMP issues and hot topics. Sessions in the afternoon were split between detailed GMP requirements for manufacturers focussing on the updated Australian Code of GMP released in January 2018 (based on PIC/S PE-009 version 13), and SME guidance particularly focusing on the role of the sponsor, for small and middle sized companies.
Finishing with a networking opportunity over a drink with our pharmaceutical industry peers, the event provided a great information session and a chance to catch up with familiar faces and meet some new contacts. The event was well supported by both industry and by the TGA, and provided plenty of opportunities to mingle and ask questions of inspectors outside of an audit scenario.
It is at events like these that you realise what an important role each of us can play in ensuring that the Australian Pharmaceutical industry continues to be identified as global leaders in providing the best quality Therapeutic Goods. The ISPE Australasia board look forward to participating in the next event.
Written by Helen Atkinson, ISPE Australasia Vice President
ISPE Event: Cleaning validation and contamination control practices - recent changes and risk based approaches
Stephanie Wilkins, Rebecca Brewer, Lynn Talomsin (TGA) , 04-05 May 2016, Sydney Olympic Park
On the morning of the 4th May 2016, 46 Australian and NZ industry delegates congregated at the Pullman Hotel in Sydney Olympic Park to meet and discuss recent changes to International Regulatory approaches to cleaning validation and contamination control. The morning session on Day 1 was opened by Australasia ISPE Vice President Ben Sauer, who welcomed the International and Interstate speakers as well as the course delegates who represented 26 different Life Science businesses from within Australia and New Zealand. Day 1 presentations began with Ms Wilkins outlining the International Regulatory landscape and recent changes however it did not take long for the seminar to move into the more detailed “nuts and bolts” of cleaning validation presented by Ms Brewer over the afternoon of day 1 and into day 2.
Ms Talomsin from the Office of Manufacturing Quality, TGA also presented an update on the current Australian Regulatory expectations in cleaning and contamination control before day 2 finished with short Q & A panel comprising the 3 speakers. The experience of industry delegates ranged from being very experienced to relatively new with respect to their knowledge in this important area. Several of the more experienced delegates were back for a refresher and to hear the very knowledgeable Ms Brewer present her views and technical approach in this area. Several delegates noticeably asked for very detailed guidance on some of the more technical elements of cleaning and these discussions benefited all participants. Very importantly, the less experienced delegates left with a sufficiently detailed information base for them to be able to progress the framework of a robust and defendable approach to cleaning validation within their own businesses.
The speakers are all experts in this area and we feel very privileged to attract them to Sydney just for this event. It was good to see and hear some of the differing views which led to some more very good discussions and interaction during the 2 day course. There was also a mix of hands on participative sessions such as the visual inspection of spiked SS coupons and then determining the detectability of different levels of surface contamination. All in all there were plenty of detailed questions being asked of the speakers which helped everyone to better understand this complex, but important topic.
The event was very well supported by both Industry and local Sponsors with a good interactive table top exhibit area for delegates to interact with each other and with local Suppliers of support products and services. The ISPE Committee thanks Ben Sauer for his drive in making this event such a success and providing great value for ISPE members and non-members alike.
Written by: Paul Fletcher, ISPE Committee