EXCiPACTTM Certification
3rd Party Certification for Pharmaceutical
Excipient Suppliers
EFCG Update at CPhI, 9th October 2012
Frithjof Holtz, Merck KGaA
EXCiPACTTM Certification
 EXCiPACTTM
 Voluntary international Good Manufacturing and Good Distribution Practice
(GMP/GDP) certification scheme for pharmaceutical excipients
 Ensures current GMP and GDP requirements applied to pharmaceutical excipients
through a recognized auditing and certification process
 Motivation for the voluntary 3rd party certification scheme:
 Regulators expect Market Authorization Holders to comply with GMP regulation
and to secure their supply chain
 One way to achieve this is by an increase of periodical, physical audits
 The economical burden associated with these requirements impacts both suppliers
and users but benefits outweigh costs
 EXCiPACT approach
 international in scope
 makes use of the existing best practice, standards and guides
 the industry response to help mitigate the risks and address the auditing challenge
 Contributors:
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EXCiPACTTM Certification Principle
ISO 9001 certification
successful EXCiPACTTM 3PAO
audit
GMP / GDP
(IPEC Guides)
EXCiPACTTM certification
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EXCiPACTTM Certification
Products and Services
 Products
 Approval/Qualification of 3rd
party audit companies issuing
the EXCiPACTTM certificate
 Excipient GMP Annex to ISO
9001 and/or ANSI standard
 Excipient GDP Annex to ISO
9001 and/ or ANSI standard
 Requirements for auditor
competency and 3rd party
audit organizations providing
certification
 Services
 Oversight of pharmaceutical
excipient manufacturer and
distributor - Certification
 Auditor competency;
development and
qualification
 Website with certification
status, including data on
compliance, list of registered
auditors
Managed by EXCiPACT Association, a not-for-profit organisation
www.excipact.org
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EXCiPACTTM Certification
The process and relationship
Excipient
user
EXCiPACT
Association
3rd Party Audit
Organisation
Excipient
Supplier
Excipient
user



Legal Agreement with 3rd Party  Agreement with supplier  Supplier passes audit report
Audit Organisations (3PAO)
 Provides audit report
to excipient user
Publish on website
and certificate to supplier  User verifies audit report
 Certificates
and certificate with EXCiPACT
 Certified bodies
 Certified Auditors meeting
competency criteria
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EXCiPACTTM Certification
Cost savings for stakeholders
Cost for EXCiPACTTM
Audit
Audit fee
Certificate fee
Internal cost
TOTAL
15,000 €
5,000 €
5 – 10,000 €
25 – 30,000 €
TOTAL COST in 3 years
30,000€
BENEFIT
Excipient Supplier
Pharmaceutical
Company
Audit reduction of 25-50% at
12 audits per year assumed
20,000 – 50,000 € per year
Audit reduction of 25-50%
50,000 – 100,000 €
per year
TOTAL SAVINGS in 3 years
60’000 – 150,000 €
TOTAL SAVINGS in 3 years
150,000 – 300,000 €
30,000 – 120,000 €
150,000 – 300,000 €
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EXCiPACTTM
Progress since CPhI 2011 (1 of 2)
 Launched publically in January 2012: 150+ delegates plus
support from FDA and MHRA
 Legal basis for EXCiPACT Association established, base funding
completed, and operational processes/staff in place
 4 x 2 day auditor training courses completed
 Legal Agreements close to signature with 3rd Party Audit
Organizations
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EXCiPACTTM
Progress since CPhI 2011 (2 of 2)
 Pilot audits planned to check the performance of GMP
and GDP standards
 Equivalent NSF-ANSI standard close to agreement
 Public webinar well received
 Many presentations and articles written to raise industry
awareness
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EXCiPACTTM and the EU Falsified
Medicines Directive (FMD)*
“… the holder of the manufacturing authorisation shall ensure that the excipients are suitable for
use in medicinal products by verifying the appropriate good manufacturing practice on the basis
of a formalised risk assessment …”
 If the Commission would propose an excipient risk assessment similar to the previous concept
of “certain excipients”, viz., classifying excipients as of low, medium or high risk.
then …
 EXCiPACTTM may replace the auditing of low and medium risk excipients by pharmaceutical
companies
and …
 could permit pharmaceutical companies to perform audits on high risk excipients or specific
needs
*Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the
Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain
of falsified medicinal products
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EXCiPACTTM Certification
Thank you
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