IPEC e-newsletter - Excipients Insight September 2017 - 19-09-17


Inside this issue


IPEC Federation sets out its plans for the coming year

In July, representatives of the IPEC Federation met in Beijing, China, to convene a board meeting, attend a workshop with the country's Centre for Drug Evaluation, CFDA, and participate in ExcipientFest Asia as a co-sponsor of the event.

The packed week provided an opportunity for the Federation to review progress with its work programme and objectives for the coming year to provide "a more refined focus," according to Patricia Rafidison, President of the organisation.

Rafidison told Excipients Insight that some projects – including preparing harmonised position papers on data integrity, atypical actives and supply chain security – have been given priority, along with risk assessment, projects on the recently-revised IPEC-PQG Good Manufacturing Practice (GMP) guide and the IPEC-Americas Excipient Information Package (EIP), and monitoring the regulatory situation for excipients in China, such as the revision of the Chinese Pharmacopoeia and new Bundling Review process.

The GMP guide has now been launched by the Federation, and work will now start to transform it into a 'how to' document aligned with ANSI/IPEC/NSF and EXCiPACT standards and in an ISO format, while the EIP will be developed into an IPEC Federation document. Additional details on the Federation work plan are available from the secretariat.

On the topic of supply chain security, work is aimed at developing strategies for performing excipient assessment and management in collaboration with other industry organisations, such as EXCiPACT, and ANSI-NSF.

Interactions with regulators continues to be high on the agenda for the Federation, with the overarching aim of encouraging scientific, risk-based global regulatory standards for excipients. The fantastic work carried out by IPEC teams on ICH Q3D is a testament to the benefits of that high-level engagement with regulatory bodies, said Rafidison.

"It's so important to give a voice to excipients, and to provide a reality check where needed," she asserted. To that end, the relationship with the Pharmacopoeial Discussion Group (PDG) continues to be fruitful, while the Federation is also committed to working towards the development of its own harmonised voluntary guidance.

The annual meeting between IPEC and the PDG took place this month – with discussion on topics including cellulosics, silicon dioxide and ICH Q3D - and a report will follow in the next edition of Excipients Insight.

The Federation's international expansion is also progressing well, and is now starting to develop a "truly global reach", said Rafidison.

IPEC India – which has three seminars planned for 2017 to raise awareness of the Association and excipient matters - is "building up nicely", she noted, and thanks to strenuous efforts by IPEC-Americas considerable progress is being made towards setting up partnerships with associations in South America, with training sessions being run in Brazil and Argentina and additional seminars planned in the coming months.

There are also plans to widen the Federation network even further with collaborations planned with additional Asian countries.

Communication is also a top priority, and a key decision taken at the Board meeting is to organise a global IPEC conference in 2019 bringing together all five regional associations.

"As regulators continue to support regional regulations, it is paramount that a risk-based approach continues to be integrated in excipient regulatory assessment and compliance," said Rafidison.

"Setting up a global conference will allow IPEC to promote the importance of excipient quality and safety, educate industry and regulators about excipients specificity globally, and increase IPEC visibility by sharing key objectives, as well as tools and guidelines developed over the years to support excipients compliance."

The IPEC Federation will next meet face-to-face for its Annual General Assembly in Bordeaux, France on 30-31 January 2018.




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