Transcript What is EXCiPACT TM

EXCiPACTTM
International Pharmaceutical
Excipients Certification
Minimize risks – maximize benefits
Why EXCiPACTTM?
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Risks in the pharmaceutical supply chain
are not just API related, excipients may be
impacted
Regulators expect Market Authorization
Holders to secure their supply chain
The appropriate way to achieve this is by a
substantial increase of periodical, physical
audits
The economical burden associated to these
requirements are impacting both
manufacturers and users
 Excipact Certification scheme is the
industry response to help mitigate the
risks and address the auditing challenge
EXCiPACTTM - Minimise the Risks, Maximise the Benefits
What is EXCiPACTTM?
Vision
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A voluntary self regulated initiative of the global pharmaceutical excipient
manufacturing, distributing and processing industry supported by excipient
users
EXCiPACTTM ensures current GMP and GDP requirements are applied to
pharmaceutical excipients through a recognized auditing and certification
process thereby increasing safety and reliability as well as transparency of
the pharmaceutical supply chain
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EXCiPACTTM is accepted from all major stakeholders including relevant
authorities globally
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As an independent organization EXCiPACTTM will be able to objectively set
cGMP and cGDP standards today and in the future
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EXCiPACTTM certification provides a cost efficient method of ensuring cGMP
and cGDP are applied throughout the pharmaceutical supply chain by
reducing the audit burden
EXCiPACTTM - Minimise the Risks, Maximise the Benefits
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EXCiPACTTM Certification
Benefits
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Ease of Access: Certification from many 3rd party audit organizations
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Evolutionary: builds on existing ISO 9001 certification and uses well known
IPEC-PQG GMP guides
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Simple: easy to understand and apply for all stakeholders
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Inclusive: applicable to all pharmaceutical excipients manufacturers and
distributors
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Permits the supplier to proactively demonstrate commitment to cGMP and
cGDP in the manufacture and supply of their pharmaceutical excipient
EXCiPACTTM - Minimise the Risks, Maximise the Benefits
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EXCiPACTTM Certification
Key Milestones for Implementation
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Development of concept / business plan by EXCiPACTTM GSC
April 2011
Cross referenced acceptance of Rx360 and EXiPACTTM
by 3.Q. 2011
Trademark protection
by 2Q. 2011
Acceptance and acknowledgement by IPEC, CEFIC...
by 3Q. 2011
Base funding completed by 90%
by 4Q. 2011
Hiring of staff, establishement of the advisory board
by 1.Q 2012
Start of operations
by 1Q. 2012
EXCiPACTTM - Minimise the Risks, Maximise the Benefits
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EXCiPACTTM Certification
Products and Services
Products
• Approval/Qualification of 3rd party
audit companies issuing the
Excipact certificate
• Excipient GMP Annex to ISO 9001
and/or ANSI standard
• Excipients GDP Annex to ISO
9001 and/ or ANSI standard
• Requirements for auditor
competency and 3rd party audit
organisations providing
certification
Services
• Oversight of pharmaceutical
excipient manufacturer and
distributor certification
• Auditor competency development
and qualification
• Website with certification status,
including statistical data on
compliance
Managed by Excipact, a not for Profit organisation
EXCiPACTTM - Minimise the Risks, Maximise the Benefits
EXCiPACTTM
International Pharmaceutical
Excipients Certification
Backups
Minimize risks – maximize benefits
EXCiPACTTM Certification
Cost savings for stakeholders
Cost for EXCiPACTTM
Audit
~
15’000€
Certificate fee ~
5’000€
Audit fee
Internal cost
Total cashout
Benefit
Audit reduction of 25 to 50%
at 12 audits p.y. assumed
~ 5 - 10’000€
20’000€ to 50’000€ savings
~ 25 - 30’000€
per year
Total cost in 3 years
30’000€
Pharmaceutical
Company
EXCiPACTTM Supplier
Audit reduction 25% to 50%
50’000€ to 100’000€ per
Year
Total Savings in 3 years
60’000€ to 150’000€
Total Savings in 3 years
150’000€ to 300’000€
30’000 – 120’000€
150’000 – 300’000€
EXCiPACTTM - Minimise the Risks, Maximise the Benefits
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EXCiPACTTM Certification
The process and relationship
Excipient
user
EXCiPACTTM
3rd Party Audit
Organisation
Excipient
Supplier
Excipient
user
Legal Agreement with
3rd party audit
Supplier passes on audit report
Agreement with supplier
Organisations
User can verify audit report and
Provides audit report
Publish list and list of
certificate with EXCiPACTTM
and Certificate
Certificates / validity on website
EXCiPACTTM - Minimise the Risks, Maximise the Benefits
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EXCiPACTTM Certification
Certification Process Flow
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EXCiPACTTM
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3RD Party Audit
Organisation
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Excipient
user
Excipient
Supplier
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Excipient
user
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Supplier selects approved 3rd party audit company
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EXCiPACTTM issues registration no to 3rd party audit company
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Audit will be performed and certificate issued
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Supplier pays audit fee (including certification fee) to 3rd party certification body
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3rd party audit company pays certification fee to EXCiPACTTM and informs about audit result
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Supplier provides audit results to excipient user and upon request audit documentation
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Excipient user can verify the audit with EXCiPACTTM
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EXCiPACTM reserves rights to attend audit or to analyse audit report in order to warrant standards
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EXCiPACTTM - Minimise the Risks, Maximise the Benefits
EXCiPACTTM Certification
Quality Assurance of Certification
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Certificate on file and accessible on the web site
Audit of third party certification body for Excipact standard compliance
Access to third party auditing process for Quality assurance purpose
Periodic review and renewal of 3rd party authorisation to certify against
Excipact standards
EXCiPACTTM - Minimise the Risks, Maximise the Benefits