Transcript FECC : The European voice of the chemical distribution ”

Achievements & Activities 2014
Work Plan 2015
GTDP Committee
12 November 2014
Frank Milek
Aug. Hedinger
Chair - GTDP Committee
Catherine Martin
Univar
Vice Chair
GTDP Committee
Achievements & Activities 2014
• Pharmaceutical ingredients
 The Committee closely monitored all activities pertaining to the
Directive on falsified medicinal products (FMD).
• The committee circulated updates, communications and various
published reports to the members.
• Revision of the guidelines on GMP for Medicinal Products: Part 1
Chapter 5: Production. The final version released in 2014 included
several of the committee’s suggestions and comments.
• Monitored activity pertaining to (a) Guidelines - risk evaluation - GMP
for pharmaceutical excipients and (b) Guidelines - GDP for Active
substances for medicinal products for human use.
 Regulatory and Quality Standards Symposium -26 March, 2014
• Speakers from the European Commission, European associations Law
firms, as well as company executives.
• EXCiPACTTM Certification scheme & asbl.
EXCiPACT - GMP/GDP auditing & certification of pharma suppliers to
reduce customer audits
 Fecc via the GTDP Committee supports EXCiPACTTM
• EXCiPACT has become a free-standing, not-for-profit association (asbl)
under Belgian law. The Articles of the Association were signed on 29
January 2014 in Cannes.
• EXCiPACT certificates have been issued in Canada, France, Germany,
The Netherlands, and Saudi Arabia.
• Fecc hosts and coordinates EXCiPACT training programmes.
 Status
• Certificates – 14+ issued.
• 4 Auditing bodies have signed an agreement with EXCiPACT – SGS,
DQS, mdc (blue inspection) & AJA Registrars.
• Auditor training programmes
• Next training programme – 18-19 November 2014.
 Food, Feed, Cosmetic ingredients
• Monitoring all relevant legislation and related activities pertaining to
Food, Feed and Cosmetic products.
• The committee regularly invited members and external experts to make
presentations on regulatory updates
 Other initiatives
• Contributed to an AT Kearney study on pharmaceutical chemicals
distribution
GTDP Committee
Work Plan 2015 (1)
• Pharmaceutical ingredients
• Systematic monitoring of all developments pertaining to pharmaceutical
ingredients and excipients as well as those related to the implementation of
the Directive on falsified medicinal products.
• Monitor the status of GDP Guidelines for APIs & Risk evaluation Guidelines
for GMP in Excipients.
• EXCiPACTTM Certification scheme
• Actively participate and contribute to the scheme and related
implementation.
• Assist and continue supporting EXCiPACT training programmes.
• Continue cooperation with IPEC Europe/Americas, EFCG and other
stakeholders.
GTDP Committee
Work Plan 2015 (2)
• Food, feed and cosmetic ingredients
• Review and follow all regulatory and legislative developments
pertaining to food, feed and cosmetic ingredients.
• Monitor the Biocidal Product Regulation for issues of relevance
• Development of tools and training
• Organise a training course or symposium for members on a hot topic.
Thank you for your attention!