IPEC Americas General Update

1. IPEC Americas General Update February 24, 2011 Dale Carter Chair, IPEC Americas

2. New Executive Committee • Chair Elect David Klug • VC Administrative Affairs John Giannone • VC Harmonization & Compendia Monographs Priscilla Zawislak • VC Membership Marc Fages • VC Science & RA David Schoneker • XC Nigel Langley • XC Gwyn Murdoch • VC user Relations < in process >

3. Budget Update • Ended 2010 - $44K over budget (made up with reserves • 2011 – under %50 dues collected but on target with last year • Dues increase in place and should help close the gap in the budget • Legislative update currently under funded

4. Early Successes • Great meeting with FDA with positive comments on Composition guide and IPEC GMP/GDP • Training webinar on Significant Change big success • Great project with FDA on spectral library

5. Future Training • March 15: Certificates of Analysis -Overview of IPEC's revised guideline based upon changing regulatory requirements.Presenter: John Giannone, Business Manager, Cognis Corporation • April 12: Excipient Pedigree - Why and how an understanding of the supply chain history of excipients is critical to the safety of drug products. Presenter: Linda Herzog, Marketing Director, Asahi Kasei America • May 17: Stability - Methods and rationale for determining excipient stability; IPEC's common sense scientific approach to stability studies for excipients stored and transported via uncontrolled conditions. Presenter: Philip Merrell, Ph.D., Technical Marketing Manager, Jost Chemical Company • June 21: Validation - Learn about IPEC's needed validation guideline on manufacturing processes, analytic methods and cleaning.  Presenter: Ann Van Meter, Senior Quality Systems Specialist, DowWolff Cellulosics.

6. 20th Anniversary & Excipient Fest • Please register and bring others from your company • Hotel rooms will run out • Gala Dinner for IPEC Foundation (bring spouse and friend to diner for $150 each) • Total Excipient Control to be introduced during our 20th Anniversary Conference on Monday • Great meet and great cocktail Sunday night

7. Legislative Initiative • Initial efforts have focused on food safety legislation, which contains third-party certification language. • Food Safety Legislation: In Late November, the Senate passed S. 510 FDA Food Safety Modernization Act. The bill passed 73-25. Since the Senate Bill creates fees, violating a constitutional requirement that tax bills must originate in the House of Representatives, an abbreviate process starts again in the House. • HR 2751 signed into Law January 4, 2011 • Contained language favorable to current 3rd party audit scheme

8. Excipact – ISO 9001 Excipient GMP Annex • Now a working sub-committee of IPEC Federation • Incubator until Excipact can launch as an independent group • IPEC Fed to provide • $ money • Staff • Sign contracts, publish docs, do legal stuff

9. BENEFITS OF EXCIPACT CERTIFICATIONTO SUPPLIERS, USERS AND PATIENTSThe role in Supplier Qualification Iain Moore, Excipact Project Co-ordinator EMA February 10th 2011 SWIPED From Excipact - Minimise the Risks, Maximise the Benefits

10. Excipact Certification • Excipact: Good Manufacturing • Practice (GMP) • Annex to ISO 9001 developed from the IPEC-PQG GMP Guide 2006 • Builds on the basic Quality Management System required in ISO 9001 and amplifies the requirements to include the GMP principles in the IPEC-PQG GMP Guide • Assessment of ISO 9001 and Excipact GMP can be simultaneous 10th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits Excipact - Minimise the Risks, Maximise the Benefits 10

11. Excipact Certification • Excipact: Good Distribution Practice • (GDP) • Annex to ISO 9001 developed from the IPEC GDP Guide 2006 • Annex contains specific requirements for Good Distribution Practices • Allowance for different distributor/trader operations • In-line with SQAS ESAD Section F&G (www.sqas.org) • Where there is overlap, GMP- and GDP - Annexes contain same requirements 10th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits Excipact - Minimise the Risks, Maximise the Benefits 11

12. Quality of auditors is critical Excipact includes a section devoted to auditor competency using ISO 19011 framework with additional requirements for GMP and GDP Alternative starting routes to qualification possible i.e. experienced in ISO 9001, GMP or GDP Considered best practices e.g. SQA and Qualified Person assessment processes Training Guide included with specific requirements for Excipients Excipact Certification 10th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits Excipact - Minimise the Risks, Maximise the Benefits 12

13. Excipact - how will it work? Excipact invites bids from 3rd Party Assessmentorganisations Legal agreement signed for them to adopt the requirements, including Auditor competency Excipact to train the trainers – who will train the auditors Excipact Website List of Third Party Certification Providers Directory of certified excipients suppliers List of certifications suspended and withdrawn Excipact Certification 10th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits Excipact - Minimise the Risks, Maximise the Benefits 13

14. Excipact - how will it work? Supplier selects 3rd Party Assessment organisation (ideally the one that already provides ISO 9001 certification) Supplier identifies if GMP and or GDP parts are needed Standard ISO certification audit process – pre audit, full audit, CAPA, Certification At least Annual surveillance audits and triennial re-certification - a frequency likely to be higher than any MAH could manage, even for high risk excipients Costs (financially and time) are comparable to ISO 9001 certification Excipact Certification 10th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits Excipact - Minimise the Risks, Maximise the Benefits 14

15. Excipact - how will it work? Audit Report lists observations and rates findings as critical, major or minor 3rd Party Technical Experts review audit report and findings, recommend certification if No critical, no major without CAPA, no minors that indicate failure of quality system element Audit Report available to pharmaceutical customer from excipient supplier – may be redacted to show that confidential information has been hidden – but substance of report will not be altered Excipact Certification 10th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits Excipact - Minimise the Risks, Maximise the Benefits 15

16. IPEA Update • Conducted five separate training workshops for pharmaceutical industry product quality personnel. • Excipient GMP auditing (2), • Excipient validation; • Changes in excipient manufacturing, their possible effects in finished products and when they need to be reported to customers. • Excipients in General • Reviewed the necessary and essential elements of manufacturing practice when an excipient material is intended for use in a finished drug formulation and data needed to establish the safety and functionality of a drug component. • Successfully obtained accreditation by ANSI of IPEA's Excipient GMP Conformance Certification Program • Signifies conformance to ISO/IEC Guide 65. • Following this 4 separate certification audits have been conducted and others are pending

17. Dancing Guitar Dave • PDA – Atypical Actives • TEC for 20th Anniversary