1 / 10

EXCiPACT TM Certification

EXCiPACT TM Certification . 3rd Party Certification for Pharmaceutical Excipient Suppliers EFCG Update at CPhI , 9 th October 2012 Frithjof Holtz, Merck KGaA. EXCiPACT TM Certification. EXCiPACT TM

creola
Download Presentation

EXCiPACT TM Certification

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. EXCiPACTTM Certification 3rd Party Certification for Pharmaceutical Excipient Suppliers EFCG Update at CPhI, 9th October 2012 Frithjof Holtz, Merck KGaA

  2. EXCiPACTTMCertification • 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 regulationand 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:

  3. EXCiPACTTM Certification Principle ISO 9001 certification successful EXCiPACTTM3PAO audit GMP / GDP (IPEC Guides) EXCiPACTTM certification

  4. EXCiPACTTM CertificationProducts 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

  5. EXCiPACTTM Certification The process and relationship • Legal Agreement with 3rd Party • Audit Organisations (3PAO) • Publish on website • Certificates • Certified bodies • Certified Auditors meeting competency criteria • Agreement with supplier • Provides audit reportand certificateto supplier • Supplier passes audit reportto excipient user • User verifies audit reportand certificate with EXCiPACT Excipient user EXCiPACT Association 3rd Party Audit Organisation Excipient Supplier Excipient user

  6. EXCiPACTTM CertificationCost savings for stakeholders Cost for EXCiPACTTM Audit Pharmaceutical Company Excipient Supplier Audit fee 15,000 € Certificate fee 5,000 € Internal cost 5 – 10,000 € Total 25 – 30,000 € 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 cost in 3 years 30,000€ Total Savings in 3 years 60’000 – 150,000 € Total Savings in 3 years 150,000 – 300,000 € Benefit 30,000 – 120,000 € 150,000 – 300,000 €

  7. EXCiPACTTMProgress 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

  8. EXCiPACTTMProgress since CPhI 2011 (2 of 2) • Pilot audits planned to check the performance of GMPand GDP standards • Equivalent NSF-ANSI standard close to agreement • Public webinar well received • Many presentations and articles written to raise industry awareness

  9. EXCiPACTTMand the EU Falsified Medicines Directive (FMD)* • “… the holder of the manufacturing authorisationshall ensure that the excipients are suitable for use in medicinal products by verifying the appropriategoodmanufacturingpractice on the basis of a formalisedriskassessment …” • If the Commission would propose an excipientriskassessment similar to the previous conceptof “certainexcipients”, viz., classifyingexcipients as of low, medium or highrisk. • then … • EXCiPACTTM may replace the auditing of lowandmediumrisk excipients by pharmaceutical companies • and … • could permit pharmaceuticalcompanies to perform audits on highriskexcipientsor 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 chainof falsified medicinal products

  10. EXCiPACTTM Certification • Thank you

More Related