January 20101 Rx-360 Overview and Structure January 2010 .
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Transcript of January 20101 Rx-360 Overview and Structure January 2010 .
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
Rx-
360
A
udito
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omp
any
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