January 2010 1

Rx-360 Overview and StructureJanuary 2010

www.Rx-360.org

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

January 2010 2

Patient safety should never be compromised as a competitive advantage

Rx-360 is inclusive

• Small and large companies

• Branded and generic

• Suppliers, distributors, brokers and manufacturers

January 2010 3

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

January 2010 4

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

January 2010 5

Consortium aims

1. Adopting established standards, auditor training, quality system

2. Shared supplier audits

3. Macro environment monitoring and information sharing

4. Technology development

January 2010 6

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

January 2010 7

Rx-360 Will Grow In Phases

Phase 1: Create infrastructure

Phase 2: Shared audit activity

Phase 3: Technology

January 2010 8

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Value PropositionCreate a Win-Win for All Interested Parties

• Patients– Confidence

• Regulators– Security, Quality

and Safety

• Suppliers– Efficiency

January 2010 9

• Biotech & Pharma Firms– Knowledge,

Efficiency, Quality, Security & Safety

• Professional Organizations– Members benefit

Standards are Required to Create a Level Playing Field

• Identify existing best practices

• Endorse best practices

• Implement quickly

• Continuously refine after successful implementation

January 2010 10

Sharing Supplier Audits Will Increase Compliance, Quality and Efficiency

Approaches being developed are:

1. Sponsor audits are initiated by a single pharmaceutical firm

2. Audits led by Rx-360 are initiated by the consortium based on input from all members

3. Subscription audits are existing audits that are redacted and placed into a secure database for member access

January 2010 11

Numerous 1 or 2 day audits will be replaced with fewer and more thorough audits thus eliminating “Audit Fatigue”

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.

January 2010 12

Other industries have been successful and we are learning from them

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

January 2010 13

Rx-360 Quality system

January 2010 14

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Decision Making

Ongoing Update

Manage CAPA

Conduct Audit

Audit Planning

Coordinate Plans

Request audits – provide product specific requests if appropriate

To agreed Standards

According to Quality System

Provide Information

Agree CAPA according to Quality System

Separately manage product specific concerns

Review information for product/ company applicability

Usage decision on supplier/ material combination

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

January 2010 15

Membership Dues will Cover Overhead

• Legal Counsel

• Software Licenses

• IT System Maintenance

• IT System Development and Enhancements

• Administration Fees

January 2010 16

LEAN and Efficient

Current RX-360 Membership

Biopharmaceutical Manufacturers:AbbottAlconAmgenAmylinAstraZenecaBaxterBMSCephalonEli LillyHospiraGSKJohnson and JohnsonMerckPfizerSanofiSchering-PloughTakedaWatson

Suppliers:ArchimicaBASFGE HealthcareHovioneMallinckrodt BakerMerck KGaASigma AldrichWest Pharmaceutical ServicesVWR

Observers:European Generic Medicines AssnInternational Pharmaceutical Excipients Council of the AmericasParenteral Drug AssociationSOCMAPharmaceutical Services Corp.SQA ServicesAPIC

January 2010 17

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.

January 2010 18

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.

January 2010 19

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.

January 2010 20

January 2010 21

As of October 30, 2009

BOARD OF DIRECTORSChair: Martin Van Trieste (Amgen)

Vice-Chair: Lynne Byers (GSK)

Audit Standards Co-Chairs: Lynne Byers (GSK) & Swroop Sahota

(Schering-Plough)

Monitoring and Reporting

Co-Chairs: Michael Huynh (SQA Services) &

Martin VanTrieste (Amgen)

Auditor Qualification Co-Chairs: Jack Brinnier (Watson) & Nigel Hamilton

(Sanofi-Aventis)

Audit Sharing Pilot Co-Chairs: Donna

Gulbinski (BMS) & Brian Johnson (Pfizer)

Quality Systems Chair: Ken Manning (Cima Labs)

Audit Database Chair: Ray Godlewski

(Baxter)

Audit Design Co-Chairs: Janice Berger (AstraZeneca) & Natalie

Garrett (Abbott)

External Relations Co-Chairs: Lynne Byers (GSK), Mike McKay (SQA

Services) & Martin VanTrieste (Amgen)

Regulatory Affairs Co-Chairs: Sharon

Bleach (AstraZeneca), Peter Kitz (Merck) & Martin

VanTrieste (Amgen)

Supply Chain Security Chair: Armando Cortes

(Cephalon)

Basic Chemicals and Raw Materials

Excipients

Primary Packaging Materials

Printed Components

APIs and Registered Intermediates

P r o j e c t M a n a g e r s : M a r y C a p i z z i & J i m J a m i e s o n ( S e c r e t a r i a t )

A U D I T W O R K I N G G R O U P S O T H E R W O R K I N G G R O U P S