Rx-360 An International Pharmaceutical Supply Chain Consortium Overview Rx-360 and the Audit Sharing Program September 2011
Rx-360 Members (Continuously updated list at www.rx-360.org) Manufacturers (24) Abbott Amgen Amylin AstraZeneca Baxter Bayer Biogen Idec Boehringer Ingelheim BMS Cephalon Eli Lilly Forest Laboratories Roche/Genentech GSK Hospira Johnson & Johnson Mylan Inc. Merck & Co. Novartis Pfizer Sanofi-Aventis Takeda Teva Watson Suppliers (24) AMPAC Fine Chemicals LLC Arch Pharmalab (USA) Inc. Avantor Performance Materials, Inc. BASF Doe & Ingalls DSM Nutritional Products Ltd Fagron GE Healthcare Hikal Hovione ISP Labochim LifeConEx Life Technologies Corp. Merck KGaA Novozymes OSO BioPharmaceuticals Manufacturing LLC SICPA Sigma Aldrich Spectrum Chemical & Laboratory Products TempTime VWR West York Container 2
Rx-360 Observers (Continuously updated list at www.rx-360.org) Auditors (7) PSC Biotech Corp. Regulatory Compliance Associates RMC Pharmaceutical Solutions Inc. Safis Solutions LLC SQA Services Inc. The Weaver Group, Inc. Auckerman Consulting Associations (11) APIC Bulk Pharmaceutical Task Force Clinton Health Access Initiative, Inc. Council for Responsible Nutrition 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) 3
Eligibility for Membership in Rx-360 http://www.rx-360.org/membership/joinrx360today/tabid/144/default.aspx The following entities are eligible to become Members, subject to exceptions noted below: manufacturers of pharmaceutical or biotechnology finished products; suppliers of ingredients and components of pharmaceutical or biotechnology products; and suppliers of services relating to the quality or safety of the pharmaceutical or biotechnology supply chain. Exceptions: Providers of auditing services concerning the quality systems for, and quality of, pharmaceutical or biotechnology products, ingredients or components are not eligible for Rx- 360 membership. Providers of auditing services are eligible to become Observers of Rx- 360. Consultants are not eligible for Rx-360 membership. The following types of entities are eligible to become Observers of Rx-360: a governmental unit or quasi-governmental unit; a non-profit trade or professional association comprised of (a) pharmaceutical or biotechnology manufacturers, (b) suppliers of pharmaceutical/biotechnology ingredients or components, (c) suppliers of services relating to the quality or safety of the pharmaceutical or biotechnology supply chain, and/or (d) individuals employed by or whose activities relate to the pharmaceutical or biotechnology industries; and auditors of the quality systems for, and quality of, pharmaceutical or biotechnology products, ingredients or components. 4
How to Become a Member http://www.rx-360.org/membership/joinrx360today/tabid/144/default.aspx For Manufacturers and Suppliers: Review the Rx-360Antitrust/Anticompetitive Policy Review the Rx-360Bylaws. Sign and submit Membership Agreement to Rx-360 Secretariat For Observers Review the Rx-360Antitrust/Anticompetitive Policy Review the Rx-360Bylaws. Sign and submit Observer Agreement to Rx-360 Secretariat 5
By-laws and Agreements -- General http://www.rx-360.org/membership/joinrx360today/tabid/144/default.aspx Rx-360 By-laws Membership Agreement Observer Agreement Anti-trust/Anti-competitive Policy 6
Agreements for Participation in Audit Sharing Program Accessed through Rx-360 Database Membership Supplemental Confidentiality Agreement Between pharmaceutical manufacturer member or supplier member and Rx-360 Confidential Disclosure Agreement (CDA) Concerning Audit by Individual Rx-360 Member Between supplier and Rx-360 7
Agreements for Participation in Audit Sharing Program (Diagram) Pharma and Suppliers (Rx-360 Members) Suppliers (Rx-360 Members and Non-members) Membership Supplemental Confidentiality Agreement CDA for Audit by Individual Rx-360 Member Rx-360 Secretariat 8
Audit Sharing Concept Share reports and responses from audits conducted by individual member companies (not by Rx-360) Companies decide individually how to use information in the audit reports/responses Suppliers can exclude specific companies (i.e., competitors) from viewing the audit reports/responses Suppliers can also vet new members joining Rx-360 who have requested access to a Shared audit report 9 9
Benefits of Sharing Audit Reports for Sponsors and Suppliers Leveraging Information Already Available Provides a Broader Picture of Quality Culture and Performance Potential for Reducing Frequency and/or Length of Audits (Routine/Due Diligence) Identify and Pre-screen New Suppliers Promote Capabilities to Consortium Competitive Advantage and Visibility to Potential Customers 10
Audit Sharing Process: Overview Sponsor & Supplier agree to share audit report/responses Sponsor & Supplier Redact reports/responses Rx-360 uploads reports/responses into database (documents controlled by CDAs) 11
Audit Sharing Process: Detail (Scope and process described in further detail in Rx-360 SOPs) Plan to Share Audit Agree to Share Audit Report (and Responses) Redact Audit Report (and Responses) Share Audit Report (and Responses) Sponsors sign CDA Sponsors identify and contact suppliers that they will audit during the year Sponsors inform suppliers of the audit sharing program and ask them to participate Sponsors register suppliers in database Supplier reviews audit sharing information and speaks with Sponsor and/or Coordinator Supplier agrees to share audit report and responses (this can be done prior to or after the audit report is issued) Supplier signs CDA and identifies Rx-360 member companies that are allowed access to report/responses Sponsor redacts audit report and sends to supplier Supplier redacts audit report (if needed) and sends to Coordinator Coordinator uploads audit report into database 12 12
Rx-360 Database (1) Accessible to Rx-360 members Managed according to a Database Protocol describing, e.g., Change management (for the database) Security Disaster recovery Naming conventions Two main sections: Consortium internal documents (e.g, minutes, slides) Shared and Join Audit Program materials 13
Rx-360 Database (2) Shared Audit Program Materials Quality Management System (Quality Manual) Audit Reports and Responses Shared Audits Standard Operating Procedures (SOPs) Database protocol Signed Agreements Membership Suppliers 14
Quality Management System (QMS) Accessed through Rx-360 database Describes the Rx-360 Quality Policy Describes the Rx-360 Code of Ethics Describes policies for Developing Rx-360 procedures Governance Roles and responsibilities Audit processes Integrates and describes the Audit Sharing and Joint Audits goals and processes Describes key aspects and purpose of database Describes document management Describes and refers to forms, templates, SOPs, protocols, and agreements relevant to audit programs 15