Rx-360 Overview and Structure

November 2015

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The problem

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Rx-360 Mission

Protect patient safety by sharing

information and developing processes

related to the integrity of the healthcare

supply chain and the quality of materials

within the supply chain.

Patient safety should never be compromised as a competitive advantage

“Rx-360s current members are pioneers that are building the

type of global, all embracing industry group of the 21st

century. Rx-360 is working to ensure that patients everywhere

can enjoy the benefits of globalization safely.”

Guy Villax, Chief Executive Officer, Hovione

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Rx-360 Objectives

Bringing Industry and Regulators Together to

Protect Patients Worldwide

Exchange public information to allow firms to

adopt best practices across industry

Bring industry experts together to develop

responses and action when the supply chain is

threatened

Act as a clearinghouse for suspicious supply

chain information

Share individual audits and conduct joint audits

Consider joint technological development for

securing supply chain and detecting

adulteration

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MembershipBroad and Inclusive

• Global

• Small and large companies

• Suppliers and manufacturers

• Branded and generic

• Regulatory agencies, standard setting bodies,

and industry organizations participate as

Observers

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Any legal entity may join Rx-360 provided that it meets the

following criteria:

Its activities relate to the research, development, manufacture, or

distribution of pharmaceutical, biotechnology, or medical device

products, including (i) research-based pharmaceutical companies,

generic pharmaceutical companies, biotechnology companies,

and medical device companies, (ii) suppliers of ingredients and

components of pharmaceutical, biotechnology, and/or medical

device products, and (iii) suppliers of services relating to the

quality or safety of the pharmaceutical, biotechnology, and/or

medical device supply chain, including distributors and

wholesalers.

Excerpt from Rx-360 Bylaws, Article IV: Membership; Section 4.01 (A): Membership Criteria

MembershipRequirements

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How We Are OrganizedOperating Model

• 501(c)(6) nonprofit organization

• Volunteer based

• Companies are members not individuals

• Not intended to replace regulatory systems or oversight

• Designed to meet competition law requirements; on-going and comprehensive antitrust compliance

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How We Are Organized

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Sharing the cost of

audits while enhancing

the security of the

supply chain and

improving patient safety

Audit Programs

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“BASF supports Rx-360 as it contributes to a secure pharmaceutical

supply chain and enables drug manufacturers and their suppliers to

cope with current and future audit challenges without compromising

product safety.”

Dr. Rainer Fendt, Head of Regulatory & GMP Compliance Pharma , BASF

“Rx-360 is a one-stop venue for understanding the issues, solutions,

and emerging regulations around the pharmaceutical supply chain.

AbbVie’s participation allows our shared service audit team to apply

enhanced focus and risk prevention with critical suppliers.”

Wes Schmidt, Divisional Vice President, Operations Quality Assurance,

AbbVie

Audit ProgramsMember Perspectives

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Audit ProgramsThree offerings

In keeping with the Rx-360 Mission, three audit programs

were developed:

1. The Joint Audit Program

2. The Shared Audit Program

3. Audit Report Licensing

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Rx-360 Joint Audit ProgramConcept

• Audits are conducted on behalf of members using third party auditing service providers

• Audit costs are equally divided amongst audit sponsors

• Prior to conducting an audit suppliers can exclude specific companies (i.e., competitors) from viewing the audit reports

• Audits may be requested by both manufacturers and

suppliers

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Rx-360 Joint Audit ProgramKey Benefits

• Reduce the number of audits at a supplier site while increasing the

effectiveness of the audits performed

• Utilize a standardized audit approach and report template

• Improve transparency of audits and improve ‘collective’ assessment

of supplier QMSs

• The report can then be licensed (with supplier approval) in lieu of

conducting an on-site audit

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Rx-360 Joint Audit ProgramQualification of Auditors

• BSI (British Standards Institution) has partnered with Rx-360 to conduct Joint Audits on behalf of the members

• Auditors register with the consortium via Rx-360 Website

• The Rx-360 Audit Operations Subgroup regularly reviews auditor qualifications to ensure they are in keeping with Rx-360 standards

• Auditors are assigned to an audit based on qualifications and location

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Rx-360 Joint Audit ProgramAudit Guidelines

API and Registered Intermediates

• Adopted from ICH Q7 with additional TSE/BSE text

Excipients

• Adopted from EXCiPACT GMP standard for excipients

Basic Chemicals/Raw Materials (including Chromatography Resins Index)

• Based on IPEC/PQG excipients audit guide

Packaging/Printed Materials

• Adopted from ISO 15378 standard

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Rx-360 Joint Audit ProgramAudit Initiatives

• The Rx-360 Joint Audit Program is branching out to

include the following initiatives:

Medical Device

Good Distribution Practices (GDP)

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Rx-360 Joint Audit ProgramSupply Chain Security

• Every Rx-360 audit has a Supply Chain Security component

• Standards were adopted from C-TPAT guidelines and internal

company guidelines and practices

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Rx-360 Joint Audit ProgramObservations

• Rx-360 Audit reports use two types of Observations

• A deficiency that indicates a critical system failure that may pose an immediate risk to patient safety or health, or may result in adverse impact to the safety, identity, strength or purity of a product.

Potentially Critical

• A deficiency against the Rx-360 audit standards, guidelines, checklists, but that are not potentially critical

Other

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Return on InvestmentHow the Joint Audit Program Works for Member Companies

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Rx-360 Audit Licensing Program

• Audit reports originating from the Joint

Audit Program may be licensed to

both members and non-members for

a fee

• A list of reports available for licensing

can be found on the Rx-360 website

using the following link Rx-360

Reports for Licensing

• Suppliers determine which

organizations may license an audit

report through an addendum to the

original CDA

• Members are provided access to the

reports and corresponding materials

through auditsPLUS

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Information

ExchangeauditsPLUS

The Rx-360 database

pulls everything

together, providing a

solution that:

Is clear and easy to

use

Puts information into

the hands of our

members

Automates

processes previously

accomplished

manually

auditsPLUS strengthens

the comprehensive Rx-

360 audit processes

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auditsPLUS

Audit Licensing

Confidentiality

Joint AuditsMember

Empowerment

Shared Audits

Understanding and

responding to risks in

the supply chain

Supply Chain Security

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“Rx-360 is one of the only organizations I know globally that is working on

the issue of supply chain security holistically. Members are collaborating on

audits, sharing intelligence, developing supply chain integrity best practices,

and collectively responding to global events such as the tsunami in Japan

last year. Incredible contributions to the industry and our patients in a few

short years!”

Brian Johnson, Senior Director, Pfizer Supply Chain Security

Rx-360 Supply Chain SecurityMember Perspective

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Rx-360 Supply Chain SecurityAccomplishments - Deliverables

• Benchmarking, and white paper describing comprehensive supply chain security program

Management Systems

• Benchmarking, development of risk model, and white paper on using risk based approaches to conveyance security

Conveyance Risk Management

• Benchmarking, white paper and framework on good practices/tools-techniques, emerging technologies, to monitor the market for criminal activity

Market Monitoring

• Points to Consider for audits/assessments; audit standard methodology; audit tools for LSP’s

Audits and Assessments of Third Party Providers

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Rx-360 Supply Chain SecurityAccomplishments - Deliverables

• Shared information on illegal diversion and how each company is impacted; identified best practice and current thinking; generated a white paper that highlighted the problem and what can/should be done to address it

Illegal Diversion

• Benchmarking, white paper on existing efforts for supply chain incidents response

Incident Management

• Highlighted risks to the integrity of pharmaceutical supply chains in a white paper

Drug Shortages

• Benchmarking, white paper on responses to the escalation of violence in cargo theft incidents in high risk areas

High Risk Cargo Theft

• Share information, knowledge, experiences and leverage learnings on how companies actually implementing requirements

Serialization Discussion Group

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Rx-360 Supply Chain SecurityAccomplishments - Deliverables

• Available at: http://www.rx-360.org/Resources/DocumentsGuidelinesPTCWhitePapers/tabid/209/Default.aspx

Webinars conducted for all the above

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Rx-360 Supply Chain SecurityAccomplishments – Risk Mitigation

Response to Crisis in Japan

• Gathered radiation exposure experts

• Shared risk assessments / models

• Developed library of radiation references

• Shared regulatory intelligence

• Monitored the regulatory environment and kept requirements library

• Monitored the “on the ground” situation in Japan

• Source of SME knowledge for regulators

• Contributed to a balanced response

• We were a service to industry and patients

• Leveraging external resource

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Rx-360 Supply Chain SecurityAccomplishments - Collaboration

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Upstream Supply Chain Security

• Benchmarking, white paper on security practices and controls that mitigate these threats of economic adulterated raw materials

High Risk Cargo Theft Discussion Group

• Share information on cargo theft incidents in high risk areas

Traceability Data Exchange Architecture

• Share current knowledge on models for sharing/storing traceability information; develop conceptual models for the interoperable sharing and exchange of data associated/required by global traceability regulations.

Secure Supply Chain Pilot

• Share experiences on FDA secure supply chain pilot program; provide feedback to FDA

Rx-360 Supply Chain SecurityInitiatives

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Rx-360 Supply Chain SecurityInitiatives –Africa

Areas of Focus

• The supply chain for products in Africa is sub-optimal

• Warehouses and distributors in general do not meet the expected standards for a secure supply chain

• Counterfeiting is a major issue in many countries

• All companies and NGOs face the same issues

• Products and patients are put at risk

• There is a general lack of understanding of how to meet the GDP standards.

Goals

• Develop educational materials for use, initially, in Africa, to educate distributors in basic Good Distribution Practice.

• Run educational workshops and help distributors to identify what they need to do to improve their own operations.

• Raise the publicity of Rx-360 in Africa and potentially with charities whoalso ship product in Africa via donation programs.

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Understanding the

needs of suppliers in the

industry

Supplier Led Working Group

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GoalsProvide a Supplier-Led forum that allows suppliers

to identify common issues and challenges and collaborate with Industry members on proposed

standardized solutions that are efficient for suppliers to execute. Foster dialogue regarding the value-

proposition of Rx-360 Supplier involvement.

In completing the Key Deliverables, the WG seeks to foster industry alignment to gain acceptance and adoption of standardized solutions by Industry

members.

ProblemComplicated communication channels between Industry and Suppliers result in duplicated efforts, frustration,

and redundancies on both sides. These inefficiencies reduce time that could be better spent enhancing other aspects of the overall drug supply chain.

Rx-360 Supplier–Led Working GroupFocus

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Rx-360 Supplier–Led Working Group

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• Rx-360 Supplier Assessment Questionnaires(SAQ) released August 2014. All modules are

available for download and use on the Rx-360 website (http://www.rx-

360.org/Suppliers/tabid/397/Default.aspx) and updated versions will be posted upon release.

• The Working Group hosted three promotional webinars on the SAQ, as well as several

outreach presentations at industry events.

Completed Deliverables

• Development of the Rx-360 Best Practices for Quality Agreements Guide (Anticipated

publication late Q3 2015)

• A white paper focused on the Management of Critical Suppliers Under Regulatory Notice

(Anticipated publication August 2015)

• Additional planned projects include:

• Development of standardized approach(es) to change notification processes

• Creation of a standard reference for uniformly accepted definitions

Current & Forthcoming Projects

Understanding and

meeting the needs of the

supply chain throughout

the World

Activities around the Globe

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Rx-360 Asia Activities

The awareness and impact of Rx-360 will significantly increase in Asia

through the creation of a regional based team, accelerating our efforts to

improve patient safety and enhance the security of the supply channels

in this critical region.

Janice Berman, VP, Takeda Pharmaceuticals U.S.A., Inc.

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Rx-30 Asia Working Group - China

Vision Statement

• Rx-360 Asia Working Group becomes a vibrant network of regional/global companies, protecting patient safety by sharing critical information, contributing to current Rx-360 workstream outputs with information specific to this region, and influencing regional regulatory activities to improve the transparency and integrity of the supply channels to protect patient health regionally and globally. The group will partner with organizations in the region that share similar goals.

Active Local Participation

• Meetings held in China with international and local company participation (suppliers and pharma)

• Subteams formed

• Audits

• Supply Chain Security

• Membership

• Initial Subteam focus

• Building/networking local teams

• Learning from established teams

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Rx-30 Asia Working Group - India

Vision Statement

• India is a large pharma market and the largest global producer and exporter of intermediates, APIs and finished product. The most important issues in need of attention are related to identifying and mitigating root causes of quality problems and supply chain security. As a neutral, open, and consensus building industry forum, Rx-360 can significantly assist in addressing these quality challenges and support India industry.

Goals

• To build Rx-360’s reputation and credibility in India – a group with tools to solve problems relevant to the global Pharma industry and supply chain

• To help understand and mitigate root causes of the most pressing quality challenges, starting with the issue of data integrity (DI), as a global challenge

• To share best practices and case studies from sites, e.g., ways that companies detect, analyze, and address DI issues and other quality challenges

• To spread awareness and understanding about Rx-360, its activities, and its audit programs, in India amongst the Indian suppliers and manufacturers.

• Position Rx -360 as a mentoring resource for the India pharma industry.

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Become a leader in supply

chain security initiatives and

set new standards across the

globe

External

Relations/Communications

and Membership

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Current Rx-360 Membership

Manufacturers (27)• AbbVie

• Amgen

• AstraZeneca

• Baxter

• Bayer

• Biogen Idec

• Boehringer Ingelheim

• BMS

• Contract Pharmaceuticals Limited Canada

• CoreRx, Inc.

• Daiichi Sankyo Co., Ltd.

• Eli Lilly

• Genentech/Roche

• GlaxoSmithKline

• Impax Laboratories Inc.

• Johnson & Johnson

• Merck & Co.

• Merz Aesthetics

• Mylan Inc.

• Novartis

• Pfizer

• Procter & Gamble

• Sanofi-Aventis

• Sigma Tau Pharmasource

• Takeda

• Teva

• Toyama Chemical Co., Ltd.

Suppliers (30)• AMPAC Fine Chemicals LLC

• Aurisco

• Avantor Performance Materials, Inc.

• BASF

• Contemporary Graphic Solutions

• DSM Nutritional Products Ltd.

• Excella GmbH

• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

• GE Healthcare

• Hikal

• Hovione

• Imperial Health Sciences

• Labochim

• LifeConEx

• Ligand

• Marken Limited

• Merck KGaA

• Neuland Laboratories Limited

• Novozymes

• OSO BioPharmaceuticals Manufacturing LLC

• Resilinc

• Sartorius AG

• Sigma Aldrich

• Sparta Systems, Inc.

• Spectrum Chemical Mfg. Corp.

• TempTime

• Thermo Fisher

• VWR

• West

• ZCL Chemicals, Ltd.

MembersObservers

Auditors (14)• Auckerman Consulting

• Berry Auditing Services, LLC

• blue inspection body GmbH

• BSI Supply Chain Solutions

• MPC Consulting LLC

• PharmaPact Consulting Services

• PSC Biotech Corp.

• Regulatory Compliance Associates

• Rephine Ltd.

• RMC Pharmaceutical Solutions Inc.

• Safis Solutions LLC

• SQA Services Inc.

• STS Consulting

• The Weaver Group, Inc.

Associations (23)• Alliance for Safe Online Pharmacies

• ANSI-ASQ National Accreditation Board

• APIC

• Bulk Pharmaceutical Task Force

• China Pharmaceutical Association of Plant & Engineering

• Consumer Healthcare Products Association (CHPA)

• Council for Responsible Nutrition

• European Fine Chemicals Group (EFCG)

• European Generic Medicines Association (EGA)

• EXCiPACT

• Generic Pharmaceutical Association (GPhA)

• Health Distribution Management Association (HDMA)

• International Society for Pharmaceutical Engineering (ISPE)

• IPEC Americas

• IPEC Europe

• NSD Bio Group

• Parenteral Drug Association (PDA)

• Pharmaceutical Quality Group (PQG)

• Pharmaceutical Research & Manufacturers of America (PhRMA)

• Pharmaceutical Supply Chain Initiative (PSCI)

• Rx Response

• USDM Life Sciences, LLC

• US Pharmacopeial Convention (USP) 39

External Relations/Communications/MembershipOutreach

• Since inception, Rx-360 has endeavoured to facilitate constructive relationships with regulators around the world and keep them informed of Rx-360’s activities

• Ensure that Rx-360’s initiatives are aligned with regulators’ expectations and priorities

• Facilitate opportunities for “one to many” meetings to encourage dialogues among groups of regulators on ways to improve supply chain security

• Rx-360 Communications Group coordinates public communications and strives to enhance the visibility of Rx-360 activities

• Rx-360 has a vibrant Monitoring and Reporting Working Group that tracks key regulatory, policy and legislative developments relevant to supply chain security and prepares timely reports that are posted on Rx-360’s public website

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Information Exchange and DatabaseExternal – The Rx-360 Website - www.rx-360.org

The Rx-360 website provides a platform for sharing information with the greater community through:

• News reports

• Flash Alerts

• Rx-360 audit guidelines

• White papers

• Newsletters

• Presentations

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How We CommunicateExternally

• Rx-360 is social, click on the labels below to follow us on:Social Media

• Smart phone APP for iPads / iPhones and Android Phones

• Click on the labels below to download the APP:Mobile

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Rx-360 Members play a

key role in moving

supply chain security

initiatives forward

Summary

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Summary Benefits of Membership

Rapidly disseminate supply chain and quality information

Identify issues and develop responses when the supply chain is threatened

Act as a clearinghouse for suspicious supply chain information

Share individual audits and conduct joint audits

Consider joint technological development for securing supply chain

and detecting adulteration

Work with regulators to solve problems

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SummaryTestimonials

“At Amgen we have already seen significant benefits from sharing audit

information. We fully support the Rx-360 audit program such that Amgen will

waive the audit of any supplier that has successfully completed an Rx-360

audit.”

Martin VanTrieste, SVP Quality, Amgen

“We will save $20-30K this year with a potential of $20-150K on vendor

audits and $40-50K on customer audits by 2015.”

Tom Beil, Vice President Quality and Regulatory Affairs, Sigma Aldrich

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SummaryPrivilege & Responsibilities

Serving patients is a

privilege that comes with

responsibilities...

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See: http://www.rx-360.org/

Or contact:

Rx-360 Secretariat

info@rx-360.org

+1 (202) 230-5607

For More Information

Contact Information

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