EXCiPACT™ Certification Scheme – an Update

IPEC Europe AGM Meeting

6th February 2015, Nice

Iain MooreBoard Member

EXCiPACT asbl

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 2014

EXCiPACTTM – minimize risks, maximize benefits 2

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

2014

EXCiPACTTM – minimize risks, maximize benefits 3

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

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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

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• 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 2014 - allows for maximum

synergies

EXCiPACTTM 2014 Calendar

EXCiPACTTM – minimize risks, maximize benefits6

• Annexes to ISO 19011 (auditing guidance) and ISO 17021 (Certifying

Body requirements) have been consolidated and aligned with the ISO

17021:2011 version of the standard

• Undergoing editing in preparation for stakeholder consultation

EXCiPACTTM Developments

EXCiPACTTM – minimize risks, maximize benefits7

• NSF/IPEC/ANSI 363-2014 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

EXCiPACTTM Developments

EXCiPACTTM – minimize risks, maximize benefits8

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 monthEXCiPACTTM – minimize risks, maximize benefits 9

• Course 18/19th November 2014 in Brussels was fully

booked

• Course 17th/18th March 2015 Brussels – only 3 places left

• Course 17th/18th November 2015 Brussels being prepared

• USA – 2 Courses in 2015

• Arlington (Washington DC) on April 22nd/23rd in IPEC-

Americas premises

• Puerto Rico April 30th/May 1st immediately after

ExcipientFest USA.

EXCiPACTTM Training Courses

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• 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

EXCiPACTTM Future Work

EXCiPACTTM – minimize risks, maximize benefits11

EXCiPACT™ Certification Scheme – an Update

Reducing the audit burden

for further information visit www.excipact.org

Thank You!

12EXCiPACTTM – minimize risks, maximize benefits