IPEC e-newsletter - Excipients Insight February 2018 - 28-02-18


Inside this issue


Patricia hands over to Priscilla at IPEC Federation

The leadership baton at the IPEC Federation formally changed hands at its meeting in January in Bordeaux, with Patricia Rafidison standing down as president after a two-year term, to be replaced by former vice president Priscilla Zawislak, who is currently also chair of IPEC-Americas. The vice chair of IPEC Europe – Frank Milek – has taken over the same role at the Federation.

In her last official role before passing over the chair of the IPEC Federation Patricia Rafidison gave a review of the last year’s activities during the IPEC Europe annual general meeting in Bordeaux on 1 February, and the progress made in the pursuit of its main objectives: managing global regulatory expectations, harmonisation of standards and promoting supply chain security.

Over the course of 2017, the Federation participated in the ICH assembly as an observer (with particular attention given to ICH Q3D on elemental impurities), continued collaboration with the Pharmacopoeial Discussion Group (PDG) on cellulosics, pre-gelatinized starch and silicon dioxide, and engaged with a series of conferences in China to spread the word of harmonization in the evolving regulatory landscape for excipients in that market.

Other highlights included a collaboration with the Parenteral Drug Association that will focus initially on the development of a technical report on risk assessment for excipient GMP, contributing to the revision of the IPEC GMP, GDP and Quality Agreement guides as well as two bilateral guides on risk assessment and co-processed excipients.

Looking to 2018 and beyond, new president Zawislak told the AGM that the priorities include completing no fewer than six Federation position papers on data integrity, atypical actives, co-processed excipients, supply chain security, gluten labelling, excipient stability during transport, continuing the project with PDA and looking into new collaborations in Mexico and Canada.

Along with the continuing role as an ICH observer and monitoring the regulatory environment in China and other countries, the Federation also intends to build on the latest revisions to the GMP and GDP guides with new ‘how to’ documents, as well as contribute to the ongoing work to align the GMP guide with ISO 9001/2015 and revise the Excipient Information Package. To make it a global document. Also in the planning stages is an inaugural global IPEC Federation conference, hopefully to take place in 2019 - watch this space!

The IPEC Federation is an umbrella organization representing regional IPECs from the Europe, the Americas, Japan, China and India.




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