EXCiPACT Certification Scheme an Update. IPEC Europe AGM Meeting 6 th February 2015, Nice. Iain Moore Board Member EXCiPACT asbl

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1 EXCiPACT Certification Scheme an Update IPEC Europe AGM Meeting 6 th February 2015, Nice Iain Moore Board Member EXCiPACT asbl

2 3rd Party Certifying Bodies mdc and SGS Signed up in 2012 and participated in Pilot Phase audits mdc has issued 5 Certificates SGS has issued 4 Certificates DQS Signed up in late 2013 Has issued one certificate AJA Registrars Have met all requirements except for a witnessed audit 10 Certificates issued before

3 3rd Party Certifying Bodies SGS issued another 5 Certificates in 2014 Capsugel Belgium Capsugel France Croda, Spain Meggle, Germany Lanolines Stella, Belgium A total of 15 Certificates issued so far Other audits are contracted or known about but this is well short of the 16 planned for

4 3rd Party Certifying Bodies SGS have contracted 3 (4?) audits in India EXCiPACT to visit this month to verify arrangements Two more audits have happened in Europe in last 2 months Further progress being made with more audits 4

5 3rd Party Certifying Bodies No new audits from the other 3 Certifying Bodies in 2014 Discussions in hand with 3 more Certifying Bodies, 2 outside Europe 5

6 EXCiPACT TM 2014 Calendar Presented at: FECC Congress Rome 28th May ExcipientFest Europe in June Delivered PQG Risk Assessment Workshop Session on Certification CPhI APV event in Dusseldorf in September Also delivered PQG Risk Assessment Workshop EXCiPACT asbl moved secretariat to (re) join IPEC Europe in the FECC Offices in Brussels at the end of allows for maximum synergies 6

7 EXCiPACT TM Developments Annexes to ISO (auditing guidance) and ISO (Certifying Body requirements) have been consolidated and aligned with the ISO 17021:2011 version of the standard Undergoing editing in preparation for stakeholder consultation 7

8 EXCiPACT TM Developments NSF/IPEC/ANSI Good Manufacturing Practices (GMP) for Pharmaceutical Excipients Published end of 2014 Now available for EXCiPACT Registered Certifying Bodies using EXCiPACT Registered Auditors to assess suppliers against and Issue EXCiPACT Certificates 8

9 Marketing Sarbari Roy had a meeting with IPEC Japan But less interest noted in Scheme Tony Scott visited Japan (courtesy of Merck) More interest noted in the Scheme! Allan Whiston will present to IPEC India this month 100 attendees expected Will be present at CPhI 2015 Allan Whiston and Tony Scott Good meeting with Dick Bonner EQPA Survey being developed for all 2000 member QPs Allan Whiston will meet a Chinese supplier and CB next month 9

10 EXCiPACT TM Training Courses Course 18/19 th November 2014 in Brussels was fully booked Course 17 th /18 th March 2015 Brussels only 3 places left Course 17 th /18 th November 2015 Brussels being prepared USA 2 Courses in 2015 Arlington (Washington DC) on April 22 nd /23 rd in IPEC- Americas premises Puerto Rico April 30 th /May 1 st immediately after ExcipientFest USA. 10

11 EXCiPACT TM Future Work Feedback from Certificate holders continues to validate the business model and intent of the Scheme It is delivering a reduction in the audit burden for suppliers and users of excipients Users are happy and are not having to do audits Suppliers are happy the users are happy It is delivering cost savings, 100% recovery in a year has been mentioned 11

12 EXCiPACT Certification Scheme an Update Reducing the audit burden for further information visit Thank You! 12