Rx-360 Overview and Structure January 2010

1. Rx-360 Overview and StructureJanuary 2010 www.Rx-360.org

2. Rx-360 Mission Create and monitor a global quality system that meets the expectations of industry and regulators, that assures patient safety by enhancing product quality and authenticity throughout the supply chain Patient safety should never be compromised as a competitive advantage

3. Rx-360 is inclusive • Small and large companies • Branded and generic • Suppliers, distributors, brokers and manufacturers

4. Rx-360 operating model • International not-for-profit organisation • Volunteer based • Broad and inclusive membership • Companies are members not individuals • Not intended to replace regulatory systems or oversight • Designed to meet competition law requirements

5. Rx-360 principles • Collaborative • Designed to leverage all parties • Flexible • Members can participate as they desire • Open and transparent • IP will be freely shared • Operating model is transparent

6. Consortium aims • Adopting established standards, auditor training, quality system • Shared supplier audits • Macro environment monitoring and information sharing • Technology development

7. Benefits to industry • More detailed audits hence greater confidence in quality of materials • Better follow up and leverage • Fewer audits for suppliers to host • Cost savings with greater confidence

8. Rx-360 Will Grow In Phases Phase 1: • Create infrastructure Phase 2: • Shared audit activity Phase 3: • Technology www.Rx-360.org

9. Value PropositionCreate a Win-Win for All Interested Parties • Patients • Confidence • Regulators • Security, Quality and Safety • Suppliers • Efficiency • Biotech & Pharma Firms • Knowledge, Efficiency, Quality, Security & Safety • Professional Organizations • Members benefit

10. Standards are Required to Create a Level Playing Field • Identify existing best practices • Endorse best practices • Implement quickly • Continuously refine after successful implementation

11. Sharing Supplier Audits Will Increase Compliance, Quality and Efficiency Approaches being developed are: • Sponsor audits are initiated by a single pharmaceutical firm • Audits led by Rx-360 are initiated by the consortium based on input from all members • Subscription audits are existing audits that are redacted and placed into a secure database for member access Numerous 1 or 2 day audits will be replaced with fewer and more thorough audits thus eliminating “Audit Fatigue”

12. We Need to Learn from Others to Accelerate Audit Sharing Success • Fair Factories Clearinghouse • Worked with the Department of Justice to obtain an antitrust waiver for this activity, (http://www.fairfactories.org/) • CHWMEG, Inc • 217 member companies that saved $27M (http://www.chwmeg.org/) • Waste facilities Audit Association • www.wfaa.org.uk • AIB International, CASE, 4FSS, GFSI, etc. Other industries have been successful and we are learning from them

13. Foundations of the audit model • Standard audit tools • GMPs (CFR and EU), ICH Q7-10 and other tools, checklists, templates • One quality system • Auditor certification and training • Content management – consistency, accuracy, depth, duration of validity • Audit coordination and distribution • Database maintenance

14. Rx-360 Quality system Decision Making Audit Planning Conduct Audit Manage CAPA Ongoing Update Rx-360 Auditor Agree CAPA according to Quality System According to Quality System Provide Information Coordinate Plans To agreed Standards Usage decision on supplier/ material combination Request audits – provide product specific requests if appropriate Separately manage product specific concerns Review information for product/ company applicability Company

15. Rx-360 Quality system Who does what: • Rx-360 establishes and maintains standards • Auditor – carries out audit and responsible for quality system CAPA • Members companies – review audit(s) and make their independent decision around product based knowledge or if required discuss additional product specific requirements/CAPA with auditee

16. Membership Dues will Cover Overhead • Legal Counsel • Software Licenses • IT System Maintenance • IT System Development and Enhancements • Administration Fees LEAN and Efficient

17. Current RX-360 Membership Biopharmaceutical Manufacturers: Abbott Alcon Amgen Amylin AstraZeneca Baxter BMS Cephalon Eli Lilly Hospira GSK Johnson and Johnson Merck Pfizer Sanofi Schering-Plough Takeda Watson Suppliers: Archimica BASF GE Healthcare Hovione Mallinckrodt Baker Merck KGaA Sigma Aldrich West Pharmaceutical Services VWR Observers: European Generic Medicines AssnInternational Pharmaceutical Excipients Council of the AmericasParenteral Drug AssociationSOCMAPharmaceutical Services Corp.SQA Services APIC

18. Scopes of Current Working Groups Audit Design: • The group is developing the infrastructure to support shared audits such as: standardized audit request form; various templates; formal agreement with auditor; and request of third party auditor. Audit Sharing Pilot: • The group is developing a process by which members will submit to the Secretariat existing audits, so that the Secretariat can provide advice on what information can/cannot be shared. This, in turn, will enable the group to build a protocol for report sharing. The Working Group will also consider the sharing of audit responses. Audit Standards: • The group is focusing on development of standards for supply chain security, APIs and registered intermediates, printed components and excipients. The group will start with APIs and registered intermediates. Text addressing supply chain security may be added into various standards as a supplement. The group has determined that environment, health, and safety issues will be considered out-of-scope for now (but could be considered in the future). The group’s focus will be on quality and GMP.

19. Scopes of Current Working Groups Auditor Qualification: • The group has identified six existing auditor qualification programs. The group will examine the APIC system among others for training auditors. (It was noted that this system appears to have some buy-in from the EMEA.) Audit Database Repository: • The group is developing a requirements document to be used to access various provides of off the shelf software to serve as a repository for shared audit information. The group will review and evaluate various software proposals and make selection recommendations to the Board of Directors. External Relations: • The group is chartered to promote Rx-360, solicit members, solicit professionals to register on our web site, and to provide the Rx-360 community with critical information and updates about Rx-360.

20. Scopes of Current Working Groups Monitoring and Reporting: • The objective of the group is to (i) review current and emerging legislation/regulation and provide summarized highlights to the Consortium; and (ii) analyze regulation/legislation with respect to its impact on the industry. Quality Management Systems: • This group is chartered to develop the Quality Management system for Rx-360 and will provide the backbone for our operation and to assure that we operate within GMP compliance Regulatory Affairs: • This group is chartered to interact with regulators around the world with the intention to: 1)keep the regulators abreast of Rx-360 activities; 2) promote the mission of activities of Rx-360 and 3) to assure that Rx-360 stays aligned with regulatory expectations. They will accomplish these tasks by routinely seeking feedback from the regulators in various forums such as 1:1 meetings and conferences. They will focus our activities where major supply chain activities take place, such as US FDA, EMEA/EC, PIC/S, WHO, China, India, etc.