excipact tm excipact tm international pharmaceutical excipients certification minimize risks –...

EXCiPACTEXCiPACTTMTM

International Pharmaceutical

Excipients Certification

Minimize risks – maximize benefits

Why EXCiPACTTM?

• Risks in the pharmaceutical supply chain are Risks in the pharmaceutical supply chain are not just API related, excipients may be not just API related, excipients may be impacted impacted

• Regulators 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

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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

EXCiPACTTM is accepted from all major stakeholders including relevant authorities globally

As an independent organization EXCiPACTTM will be able to objectively set cGMP and cGDP standards today and in the future

EXCiPACTTM certification provides a cost efficient method of ensuring cGMP and cGDP are applied throughout the pharmaceutical supply chain by reducing the audit burden

What is EXCiPACTTM?

VisionVision


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Ease of Access: Certification from many 3rd party audit organizations

Evolutionary: builds on existing ISO 9001 certification and uses well known IPEC-PQG GMP guides

Simple: easy to understand and apply for all stakeholders

Inclusive: applicable to all pharmaceutical excipients manufacturers and distributors

Permits the supplier to proactively demonstrate commitment to cGMP and cGDP in the manufacture and supply of their pharmaceutical excipient

EXCiPACTEXCiPACTTMTM Certification CertificationBenefits


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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

EXCiPACTEXCiPACTTMTM Certification Certification Key Milestones for Implementation


EXCiPACTTM CertificationProducts and Services

Managed by Excipact, a not for Profit organisation


EXCiPACTEXCiPACTTMTM

International Pharmaceutical

Excipients Certification

Backups

Minimize risks – maximize benefits

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EXCiPACTEXCiPACTTMTM Certification Certification

Cost savings for stakeholdersCost savings for stakeholders

Cost for EXCiPACTTM Audit

EXCiPACTTM Supplier Pharmaceutical Company

Audit fee ~ 15’000€

Certificate fee ~ 5’000€

Internal cost ~ 5 - 10’000€

Total cashout ~ 25 - 30’000€

Total cost in 3 years30’000€

Audit reduction of 25 to 50% at 12 audits p.y. assumed

20’000€ to 50’000€ savings

per year

Audit reduction 25% to 50%

50’000€ to 100’000€ per

Year

Total Savings in 3 years60’000€ to 150’000€

Total Savings in 3 years150’000€ to 300’000€

Benefit 30’000 – 120’000€ 150’000 – 300’000€


Supplier passes on audit reportUser can verify audit report and

certificate with EXCiPACTTM

Agreement with supplierProvides audit report

and Certificate

Legal Agreement with3rd party auditOrganisations

Publish list and list of Certificates / validity on website

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EXCiPACTTM Certification The process and relationship

EXCiPACTTM 3rd Party Audit Organisation

Excipient user

ExcipientSupplier

Excipient user


1. Supplier selects approved 3rd party audit company

2. EXCiPACTTM issues registration no to 3rd party audit company

3. Audit will be performed and certificate issued

4. Supplier pays audit fee (including certification fee) to 3rd party certification body

5. 3rd party audit company pays certification fee to EXCiPACTTM and informs about audit result

6. Supplier provides audit results to excipient user and upon request audit documentation

7. Excipient user can verify the audit with EXCiPACTTM

8. EXCiPACTM reserves rights to attend audit or to analyse audit report in order to warrant standards10

EXCiPACTTM CertificationCertification Process Flow

EXCiPACTTM 3RD Party Audit Organisation

Excipient user

ExcipientSupplier

Excipient user1

2

34

56

6

7

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EXCiPACTEXCiPACTTMTM Certification Certification

Quality Assurance of Certification

• 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


excipact tm excipact tm international pharmaceutical excipients certification minimize risks –...

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