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Rx-360 in Action:                                      An inside look at the Joint Audit Programwww.Rx-360.org            ...
Today                                                        Supply                                                       ...
The problem                            May 7, 2007                            80 children die in Haiti due to contaminated...
Rx-360 Mission          To enhance patient safety by developing a          global quality system that helps members       ...
Rx-360 Aims1. To exchange public information to allow firms to adopt   best practices.2. To act as a clearinghouse for sus...
Growth in Phases1: Create organizational infrastructure2: Share individual audits and conduct joint audits3: Fund technolo...
Current Status of Rx-360• Rx-360 was incorporated on June 3rd 2009• Currently over 65 organizations globally have  joined ...
Rx-360 Membership Now Tops 65! Members                                                                         Observers M...
Sharing Supplier Audits Will IncreaseCompliance, Quality and EfficiencyApproaches being developed are:1. Rx-360 Joint Audi...
Rx-360 Joint Audit Standards• Identify and adopt existing audit standards /  guidelines• Identify gaps where existing audi...
Rx-360 Joint Audits              Audit                            Conduct              Review                     Ongoing ...
Pilot Audit Program                  Audit Design Working Group (ADWG)         Objective: Design an Rx-360 sponsored syste...
Guidelines/Standards/Checklists• API and Registered Intermediates       – Adopted ICH Q7       – Additional TSE/BSE text• ...
Supply Chain Security Checklist1. Premises2. Quality Management System3. Incoming Shipments4. Manufacturing5. Packaging/Re...
The SQA Experience•    Supplier coordination & communication•    No ‘Criticals’•    Tools and preparation•    Variation in...
Pilot Debrief with all Auditors•    Consistent experiences in all areas•    Orientation and Training – to evolve with the ...
Pilot Next Steps•    Close out all Pilot activity•    Consolidate and act on feedback•    Report to Rx-360 Membership•    ...
Thanks and Questions                 Gerard Pearce       gpearce@sqaservices.com             310-802-4448                 ...
Supplementary slidesPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
Operating Model• 505(c)(6) nonprofit organization• Volunteer based• Companies are members not individuals• Not intended to...
Broad and Inclusive Membership•    Small and large companies•    Branded and generic•    Based in US, Europe, and elsewher...
Current Rx-360 Working Groups•    Audit Design (Rx-360 Joint Audits)•    Auditor Qualification (Rx-360 Joint Audits)•    A...
Objectives of Current Working GroupsAudit Design• Design an Rx-360 sponsored system for voluntary joint audits of  supplie...
Objectives of Current Working Groups Audit Standards • Identify existing manufacturing quality standards for pharmaceutica...
Objectives of Current Working GroupsAudit Database• Implement a secure database for storage and retrieval of audit  report...
Objectives of Current Working Groups  Regulatory Affairs  • Facilitate constructive relationships with regulators around t...
Objectives of Current Working GroupsJapan Supply Chain Threat• This working group is identifying risks as a result of the ...
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PDA Southern California RX 360 Pilot Update

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Transcript of "PDA Southern California RX 360 Pilot Update"

  1. 1. Rx-360 in Action: An inside look at the Joint Audit Programwww.Rx-360.org Gerard Pearce Executive Vice President SQA Services, Inc. PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  2. 2. Today Supply Chain Pilot Security Shared Audit Audits ProgramPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  3. 3. The problem May 7, 2007 80 children die in Haiti due to contaminated glycerin in acetaminophen syrup 3PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  4. 4. Rx-360 Mission To enhance patient safety by developing a global quality system that helps members ensure product quality and authenticity throughout the pharmaceutical supply chain.Patient safety should never be compromised as a competitive advantage PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  5. 5. Rx-360 Aims1. To exchange public information to allow firms to adopt best practices.2. To act as a clearinghouse for suspicious supply chain information.3. To share individual audits and conduct joint audits.4. To consider joint technological development for securing supply chain and detecting adulteration.PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  6. 6. Growth in Phases1: Create organizational infrastructure2: Share individual audits and conduct joint audits3: Fund technological development Rx-360 Working Groups • Audit Design (Rx-360 Joint Audits) • Audit Database • Auditor Qualification (Rx-360 Joint Audits) • Regulatory Affairs • Audit Standards (Rx-360 Joint Audits) • External Relations • Audit Sharing (Sharing of Individual Audits) • Monitoring and Reporting • Rx-360 Quality Management System • Japan Supply Chain Threat • Various Supply Chain, Security and LogisticsPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  7. 7. Current Status of Rx-360• Rx-360 was incorporated on June 3rd 2009• Currently over 65 organizations globally have joined Rx-360 as members or observers• Several meetings have taken place with regulators (EMA, FDA, WHO & PIC/S)• FTC staff have reviewed Rx-360 proposed auditing programs and issued favorable opinion regarding antitrust legal compliancePDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  8. 8. Rx-360 Membership Now Tops 65! Members Observers Manufacturers (24) Suppliers (24) Auditors (6) • Abbott • AMPAC Fine Chemicals LLC • PSC Biotech Corp. • Amgen • Arch Pharmalabs • Regulatory Compliance Associates • Amylin • Avantor Performance • RMC Pharmaceutical Solutions Inc. • AstraZeneca Materials • Safis Solutions LLC • Baxter • BASF • SQA Services Inc. • Bayer • Doe & Ingalls • The Weaver Group, Inc. • Biogen Idec • DSM Nutritional Products • Boehringer Ingelheim Ltd. • Bristol-Myers Squibb • Fagron Associations (10) • Cephalon • GE Healthcare • APIC • Eli Lilly • Hikal • Council for Responsible Nutrition • Forest Labs • Hovione • Consumer Healthcare Products Ass (CHPA) • Genentech • ISP • European Fine Chemicals Group (EFCG) • GlaxoSmithKline • Labochim • European Generic Medicines Association • Hospira • LifeConEx (EGA) • Johnson & Johnson • Life Technologies • IPEC Americas • Merck & Co., Inc. • Merck KGaA • IPEC Europe • Mylan • Novozymes • NSD Bio Group • Novartis • OSO BioPharmaceuticals • Pfizer • SICPA Holding • Parenteral Drug Association (PDA) • sanofi-aventis • Sigma Aldrich • Pharmaceutical Quality Group (PQG) • Takeda • Spectrum Chemical & • Teva Laboratory Products • Watson • TempTime • VWR • West • York ContainerPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  9. 9. Sharing Supplier Audits Will IncreaseCompliance, Quality and EfficiencyApproaches being developed are:1. Rx-360 Joint Audits are initiated by the consortium based on input from all members2. Audit sharing uses existing audits that are redacted and placed into a secure database for member access Numerous 1 or 2 day audits of a supplier will be replaced with fewer but more thorough Rx-360 Joint Audits, thus eliminating “Audit Fatigue”PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  10. 10. Rx-360 Joint Audit Standards• Identify and adopt existing audit standards / guidelines• Identify gaps where existing audit standards / guidelines do not exist and develop Rx-360 audit standards to fill those gaps• Continuously refine after successful implementationPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  11. 11. Rx-360 Joint Audits Audit Conduct Review Ongoing Decision Planning Audit Proposed Update Making CAPAs To Rx-360 Auditor / Share info Rx-360 Coordinate reviewers plans audit provided by standards opine on supplier adequacy Request audits Individually Review Independent decide onIndividual information decision makingMembers acceptability for product/ on use of Separately company supplier/material manage applicability product specific concernsPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  12. 12. Pilot Audit Program Audit Design Working Group (ADWG) Objective: Design an Rx-360 sponsored system for voluntary joint audits of suppliers using agreed-upon quality and audit standards • Three qualified third-party Auditors • Focused on US, EU and Asia (19 total) • ‘Stress Test’ on process, tools and training • Commodity-based Guidelines plus SecurityPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  13. 13. Guidelines/Standards/Checklists• API and Registered Intermediates – Adopted ICH Q7 – Additional TSE/BSE text• Supply Chain Security – Based on review of C-TPAT guidelines and internal company guidelines and practices• Excipients – Adopted IPEC/PQG excipients audit guide and standard• Basic Chemicals/Raw Materials – Based on IPEC/PQG excipients audit guide and draft standard• Packaging/Printed Materials – In developmentPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  14. 14. Supply Chain Security Checklist1. Premises2. Quality Management System3. Incoming Shipments4. Manufacturing5. Packaging/Repackaging and/or Relabeling6. Distributors7. Outgoing Shipments8. Information Technology Security9. Documents10.Organization and Personnel Awareness11.Planning and ManagementPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  15. 15. The SQA Experience• Supplier coordination & communication• No ‘Criticals’• Tools and preparation• Variation in results format and style• Exceptions and escalationPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  16. 16. Pilot Debrief with all Auditors• Consistent experiences in all areas• Orientation and Training – to evolve with the tools• Standards – application and adaptation• Forms – refinement• Conduct of the Audit – cautiously positive• Audit Report Review Process – timing, confidentiality• Corrective and Preventative Actions – review, escalationPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  17. 17. Pilot Next Steps• Close out all Pilot activity• Consolidate and act on feedback• Report to Rx-360 Membership• Post-pilot Audit Request Form ‘live’, with Q4 audit requests already receivedPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  18. 18. Thanks and Questions Gerard Pearce gpearce@sqaservices.com 310-802-4448 Supply Chain Pilot Security Shared Audit Audits ProgramPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  19. 19. Supplementary slidesPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  20. 20. Operating Model• 505(c)(6) nonprofit organization• Volunteer based• Companies are members not individuals• Not intended to replace regulatory systems or oversight• Designed to meet competition law requirementsPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  21. 21. Broad and Inclusive Membership• Small and large companies• Branded and generic• Based in US, Europe, and elsewhere• Suppliers and manufacturersPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  22. 22. Current Rx-360 Working Groups• Audit Design (Rx-360 Joint Audits)• Auditor Qualification (Rx-360 Joint Audits)• Audit Standards (Rx-360 Joint Audits)• Audit Sharing (Sharing of Individual Audits)• Audit Database• Rx-360 Quality Management System• Regulatory Affairs• External Relations• Monitoring and Reporting• Various Supply Chain, Security and Logistics• Japan Supply Chain ThreatPDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  23. 23. Objectives of Current Working GroupsAudit Design• Design an Rx-360 sponsored system for voluntary joint audits of suppliers using agreed upon quality and audit standards.Auditor Qualification• Identify and agree the relevant auditor qualifications, background, and experience necessary for the performance of supplier GMP and quality audits within the Rx-360 auditing program. Identify auditing certification/accreditation programs and compare the requirements under these programs for certification/accreditation to the identified Rx-360 minimum requirements for auditors. Identify a list of auditing service providers and compare their auditor qualifications to the identified Rx-360 minimum requirements for auditors. Make recommendations to the Rx-360 Board on the process for selection of Rx-360 auditors.PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  24. 24. Objectives of Current Working Groups Audit Standards • Identify existing manufacturing quality standards for pharmaceutical suppliers of raw materials, excipients, APIs, and packaging components (including printed components). Identify gaps in standards for which additional guidelines are required, e.g., auditing the security aspects of the supply chain. Make recommendations to the Board on standards to which Rx-360 audits should be conducted. Audit Sharing • Develop and pilot a process to share audit reports among consortium members for audits that were originally conducted on behalf of individual members.PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  25. 25. Objectives of Current Working GroupsAudit Database• Implement a secure database for storage and retrieval of audit reports, audit responses, and other audit information from the Rx- 360 Audit Programs.Quality Management Systems• Design and manage the overall quality systems for Rx-360, including for the Rx-360 joint auditing and audit sharing programs. Provide oversight of the overall effectiveness of the quality systems supporting Rx-360, including evaluating effectiveness checks applicable to the Rx-360 quality systems.PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  26. 26. Objectives of Current Working Groups Regulatory Affairs • 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. External Relations • Develop legal compliance program for Rx-360 communications (e.g., website, flash alerts). Issue Rx-360 communications (e.g., reports, flash alerts, newsletters). Enhance visibility of Rx-360 activities. Monitoring and Reporting • Monitor and report on regulatory, policy and legislative developments relevant to supply chain integrity.PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
  27. 27. Objectives of Current Working GroupsJapan Supply Chain Threat• This working group is identifying risks as a result of the Japanese earthquake, tsunami, power interruptions and nuclear power plant accidents. They have identified methods to mitigate risks and are sharing best practices to help ensure pharmaceutical supplies in Japan and the safety of materials and pharmaceuticals exported from Japan.PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
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