1 / 18

Introduction to Rx-360 An International Pharmaceutical Supply Chain Consortium Lisa McClintock

Introduction to Rx-360 An International Pharmaceutical Supply Chain Consortium Lisa McClintock Director of Supplier Quality Amgen. 1. Rx-360’s Mission Is to Protect Patients.

varian
Download Presentation

Introduction to Rx-360 An International Pharmaceutical Supply Chain Consortium Lisa McClintock

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Introduction to Rx-360 An International Pharmaceutical Supply Chain Consortium Lisa McClintock Director of Supplier Quality Amgen 1

  2. Rx-360’s Mission Is to Protect Patients 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 must never be compromised as a competitive advantage 2

  3. The Rx-360 Operating Model is Simple • 505(c)(6) nonprofit organization • Run by Secretariat • Companies are members, not individuals • Success depends on volunteers • Not intended to replace regulatory systems or regulatory oversight • Designed to meet legal requirements

  4. Membership Requirements are Designed to Encourage Participation • Small and large companies • Branded and generic • Global in nature • Suppliers and manufacturers • Inexpensive

  5. Current Status of Rx-360 • Rx-360 was incorporated on June 3, 2009 • Currently 60+ 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 compliance

  6. Rx-360 Membership Now Tops 60! Members Observers • Auditors (6) • PSC Biotech Corp. • Regulatory Compliance • Associates • RMC Pharmaceutical • Solutions Inc. • Safis Solutions LLC • SQA Services Inc. • The Weaver Group, Inc. • Associations (10) • APIC • Council for Responsible Nutrition • Consumer Healthcare Products Ass (CHPA) • European Fine Chemicals Group (EFCG) • European Generic Medicines Association (EGA) • IPEC Americas • IPEC Europe • NSD Bio Group • Parenteral Drug Association (PDA) • Pharmaceutical Quality Group (PQG) • Manufacturers (23) • Abbott • Amgen • Amylin • AstraZeneca • Baxter • Bayer • Biogen Idec • Boehringer Ingelheim • Bristol-Myers Squibb • Cephalon • Eli Lilly • Genentech • GlaxoSmithKline • Hospira • Johnson & Johnson • Life Technologies • Merck & Co., Inc. • Novartis • Pfizer • sanofi-aventis • Takeda • Teva • Watson • Suppliers(21) • AMPAC Fine Chemicals LLC • Arch Pharmalabs • Avantor Performance Materials • BASF • Doe & Ingalls • DSM Nutritional Products Ltd. • Fagron • GE Healthcare • Hikal • Hovione • ISP • Labochim • LifeConEx • Merck KGaA • OSO BioPharmaceuticals • SICPA Holding • Sigma Aldrich • Spectrum Chemical & Laboratory Products • TempTime • VWR • West

  7. 7

  8. Rx-360 Distributes Information via Web Site, Flash Alerts, Twitter, Linkedin, & Facebook

  9. The Website Draws ~15,000 Visitors per Month 9

  10. Educational Videos Help Get the Message Out 10

  11. Responded to Supply Chain Threat from Japan Earthquake, Tsunami & Nuclear Plant • Task force formed consisting of 26 members with various expertise including nuclear safety • Sent out several Flash Report and created a Web Page with regulatory requirements and best practices • Continually monitoring the situation and rapidly responding to new information

  12. Rx-360 Learned of a Threat and Developed Technology to Detect It! Determination of Adulteration of Acetonitrile using Gas Chromatography with Thermal Conductivity Detection

  13. Rx-360 Has Made Great Progress Endorsing and Creating Standards • API auditing (ICHQ7/APIC standard) • Rx-360 Security Standard • Excipients (endorsed the IPEC standard) • Basic Chemicals (based upon ISO 9001:2008) 13

  14. We Are Poised to Transform How Our Industry Does Supplier Audits Rx-360 Led Audits are initiated by the consortium based on input from all members Subscription audits are existing audits that are redacted and placed into a secure database for member access Numerous 1 or 2 day audits will be replaced with fewer & more thorough audits thus eliminating “Audit Fatigue” 14

  15. Rx-360’s Momentum Holds Great Promise for 2011 and Beyond We will continue to adapt to new approaches and relentlessly share information Endorse and Create Standards Launch the Shared Audit Program Embrace and Adopt Technologies 16

  16. Register as a User on www.Rx-360.org and Receive Valuable Industry News

  17. Thank you! 18

More Related