rx 360 fdanews supplier quality mgt congress pres rev b 97

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Gerard PearceMike McKay

Working Together to OvercomeGlobal Supply Chain Challenges

- introducing Rx-360

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May 7, 200780 children die in Haiti due to contaminatedglycerin in acetaminophen syrup

MHRA Warns Diabetics About Counterfeit Insulin Pen NeedlesCounterfeit batch of insulin pen needles found circulating in UK supply systemThe Medicines and Healthcare products Regulatory Agency (MHRA) is today warning diabetics about a counterfeit batch of insulin pen needles that are circulating in the UK.

Not If… But When and Where

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g“Illicit, the Dark Trade”

• The criminal element is present, active, and business savvy

• ‘Benign’ consumer actions may have tragic consequences

$1000

$10,000

Counterfeit DVDs

$100,000

Illegal drugs

$1,000,000

Counterfeit medicine

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gChallenges in supplier oversight

• Supply Chain outpacing control function• Redundancy and Duplication• Limited visibility• Reduced effectiveness

…moral and commercial pressure

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gA Joint Approach to Supplier Evaluation

1. Adopting established standards, auditor training, quality system

2. Shared supplier audits3. Macro environment monitoring and

information sharing4. Technology development

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gBenefits to Industry

• More detailed auditsmore information

greater confidence in quality of materials and reliability of suppliers and supply chain

• Better follow up and corrective actions• Fewer audits for suppliers to host

Cost savings with greater confidence

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gValue Proposition:

Create a Win-Win for All Interested Parties

• Patients– Confidence

• Regulators– Security, Quality

and Safety

• Suppliers– Efficiency

• Healthcare Firms– Knowledge,

Efficiency, Quality, Security & Safety

• Professional Organizations– Members benefit

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gRx-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

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gRx-360 Principles

• Collaborative– Designed to leverage all parties

• Flexible– Members can participate as they desire

• Open and transparent– Information will be freely shared– Operating model is transparent

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gRx-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 comply with anti-competition

laws and regulations

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gRx-360 Will Grow in Phases

Phase 1 Create infrastructure

Phase 2 Shared audit activity

Phase 3 Technology

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gInfrastructure – Working Groups - Action

• Identify existing best practices • Endorse best practices • Implement quickly• Continuously refine after successful

implementation

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gSharing Supplier Audits Will Increase

Compliance, Quality and Efficiency

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

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

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

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Your audit goal

Rx-360 audits you sponsor

and share for a credit

Rx-360 audit subscription

audits you can’t get done

places you can’t go

Audits you perform

independently

A Supplier Evaluation Proposition:

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How will it work? - Rx-360-led audits

RX-360 database

SupplierMembers

quality & regulatory

quality & regulatory

quality & regulatory

quality & regulatory

quality & regulatory

audit requests

content management

Rx-360-led audit & CAPA

approval, permission

controlled access through subscription

consolidated request

and payment

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RX-360 database

• find it• request/subscribe

to it• access details and

related actions• receive updates on

status• track it on your

dashboard

Supplier

request

request

permission

payment

access

original sponsor

credit

How will it work? – Subscribed audits

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standard audit tools21 CFR 210/211, ICH Q7/Q10, other

standards? process?, checklists?, templates? audit duration?

content managementRx-360 review of consistency, accuracy, depth; expiration?

auditor certification and training

prerequisites?, training?, examination?, monitoring?

audit coordination & distribution

requests, scheduling, security, permissions, NDAs, credits

databaserepository, process flow,

subscriptions, critical metrics dashboard

…or trusting the auditFoundations of the shared audit model

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gTechnology is Critical for

Prevention and Detection

18

Working with universities, pool resources to develop innovative technologies for:

of…– Repackaged– Relabeled– Adulteration– Counterfeit

– Seals– Taggants– Anti-counterfeiting

Prevention

Detection

using…– Bar Codes– RFID– E-Pedigree

using…– Rapid– User Friendly– Portable– Robust & Reliable

By pooling resources, advances in technologies will occur faster

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gWe Need to Learn from Others to Accelerate Audit Sharing Success

• Fair Factories Clearinghouse – Work with the Department of Justice to

obtain an antitrust waiver for this activity, similar to what was obtained for the apparel industry (http://www.fairfactories.org/)

• CHWMEG, Inc – 217 member companies that saved $27M• http://www.chwmeg.org/

• AIB International, CASE, 4FSS, GFSI, etc.

Other industries have been successful and we are learning from them!

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gMonitoring will Provide

Critical Information• Flash Reports• Clearinghouse for suspicious incidents or shortages• Engage firms to conduct supply chain surveillance• Assemble teams to conduct risk assessments• Develop proactive measures to prevent negative

consequences• Develop methods of detection

Reporting, trending and early dissemination of informationwill prevent larger, more significant problems

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gMembership Dues aimed at Overhead

• Legal Counsel• Software Licenses• IT System Maintenance• IT System Development and Enhancements• Administration Fees

Holistic, Comprehensive, LEAN and Efficient

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gRx-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

decision around product based knowledge or if required discuss additional product specific requirements/CAPA with auditee

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gJune 5th US Launch Meeting

A Call to ActionMartin VanTrieste, Amgen, VP Quality

US Department of CommerceJeff Gren, US DOC, Director

Legal ConsiderationsMary Devlin Capizzi, Drinker, Biddle & Reath LLP

Three Audit Models ReviewGerard Pearce, SQA Services, VP

Fair Factories ClearinghouseMarianne Voss, FFC

Supply Chain Risk ManagementVel Dhinagaravel, Beroe Consulting

Illicit: The Dark TradeHelen Fitzwilliam, film director

Wrap upJaneen Skutnik, Pfizer, Director

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gAttended by 130 Industry, Supplier, Regulatory,

& Media Representatives

• 100% agreed that Rx-360 was needed• 64% stated they were certain or likely to join • Which Rx-360 objective they support…

– 61% shared audits– 20% adopting industry standards– 13% monitoring– 6% technologies

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gNext Steps for Rx-360

Mar ’09 Launched www.Rx-360.org web-site

Apr ’09 Initiated news distribution to registered users

June ’09 Incorporated Rx-360 as a 501(c)(6) non-profit organization

July ’09 Appoint interim Board of Directors with election by year end

July ’09 Created 9 working groupsAudit Standards, Audit Process, Auditor Qualification, Audit Database, Membership, Regulatory Liaison, Surveillance, Rx-360 QMS

Ongoing Bring on member companies, target is 50

Nov ’09 European Launch Meeting

Dec ’09 Hold Board Elections

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gSince April 2009 Rx-360 Has Distributed Industry

News to Registered Users

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gRegister as a User on www.Rx-360.org

and Receive Valuable Industry News

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A call to action!

May 7, 200780 children die in Haiti due to contaminatedglycerin in acetaminophen syrup

MHRA Warns Diabetics About Counterfeit Insulin Pen NeedlesCounterfeit batch of insulin pen needles found circulating in UK supply systemThe Medicines and Healthcare products Regulatory Agency (MHRA) is today warning diabetics about a counterfeit batch of insulin pen needles that are circulating in the UK.

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THANK YOUGerard Pearcegpearce@sqaservices.com310-802-4448www.sqaservices.com