IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17


Inside this issue


EXCiPACT looks back on transformative year

2017 has proved to be EXCiPACT’s best year ever for certifications and re-certifications, with numbers rising globally by over 50% to 62 during the year and many more expected in early 2018.

Another milestone was also passed with the completion of the organization’s restructuring and the appointment of Alain Becart, ex-Sanofi, as Quality Manager and Dale Carter joining the Board as the IPEC-Americas representative.

From a technical perspective, EXCiPACT’s revised 2017 standards were published in November - replacing the original 2012 edition – and sincere thanks go to Iain Moore and his team who worked so hard on the project and successfully aligned the new ISO 9001:2O15 and ISO/IEC 17021-1:2015 standards with the existing GMP and GDP standards to create the new standards.

The transition to the new standards for new certifications, re-certifications and surveillance audits will be effective from 1 April, 2018, and a summary of the changes made in creating the new version will shortly be available on the EXCiPACT website. A Chinese language version is in preparation and should be ready for publication early in the first quarter of 2018.

Also published in November was EXCiPACT’s redesigned website making it easier for users of mobile phones, tablets, laptops and desktop computers to quickly find what they need. A revised logo (see above) was also launched at the same time.

Other highlights in 2017 included hosting EXCiPACT’s most successful webinar to date in October, with more than 200 registered delegates from around the world. EXCiPACT President Kevin McGlue gave the presentation and answered questions during and after the event.

Another successful China workshop organised by a local consultant was held in Shanghai in July where EXCiPACT Vice-President, Dr Sabari Roy, made two presentations. With the help of IPEC China, the association participated in CPhI China and ExcipientFest Asia.

Three new auditors completed two-day training courses in Milan in September, and Certiquality srl based in Italy became EXCiPACT’s seventh Registered Certification Body this year. To celebrate, the two organizations shared a stand at the annual AFI Seminar in Rimini in June.

It was also gratifying to be nominated as one of five finalists of the 2017 CPhI Annual Awards in the Regulatory category in October in Frankfurt.

“We look forward to building on this year’s success in 2018 with a revitalised marketing programme,” commented McGlue, who added that annual business review meetings with our Certification Bodies, which provide an opportunity to review progress and to share ideas for growing the business on a cooperative basis, have now largely been completed.

“Our annual General Assembly will be held alongside the IPEC Europe Annual Excipients Forum in Bordeaux on 31 January 2018,” he added.




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