rx 360 fdanews supplier quality mgt congress pres rev b 97
DESCRIPTION
Pharmaceutical industry consortium for improved supplier quality and control.TRANSCRIPT
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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
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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.
