IPEC Americas General Update February 24 2011 Dale

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

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 > 2

Budget Update • Ended 2010 - $44 K 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 3

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 4

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, Dow. Wolff Cellulosics. 5

20 th 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 20 th Anniversary Conference on Monday • Great meet and great cocktail Sunday night 6

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 3 rd party audit scheme 7

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 8

BENEFITS OF EXCIPACT CERTIFICATION TO SUPPLIERS, USERS AND PATIENTS The role in Supplier Qualification SWIPED From Iain Moore, Excipact Project Co-ordinator EMA February 10 th 2011 Excipact - Minimise the Risks, Maximise the Benefits

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 10 th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits 10

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 10 th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits 11

Excipact Certification 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 10 th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits 12

Excipact Certification Excipact - how will it work? · Excipact invites bids from 3 rd Party Assessment organisations · 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 10 th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits 13

Excipact Certification Excipact - how will it work? · Supplier selects 3 rd 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 recertification - 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 10 th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits 14

Excipact Certification Excipact - how will it work? · Audit Report lists observations and rates findings as critical, major or minor · 3 rd Party Technical Experts review audit report and findings, recommend certification if ü 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 10 th Feb 2011 London Excipact - Minimise the Risks, Maximise the Benefits 15

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 16

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