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Ingredient Supplier Qualification

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  1. Ingredient Supplier Qualification Implementation of the SIDI™ protocol

  2. “Nutrition is not just a discipline, it is an agenda” - late Jean Mayer, former President of Tufts University and founder of the Friedman School of Nutrition Science and Policy “Quality is not just a regulatory requirement, it is an agenda” - ????

  3. GMP Challenges • Effective control over ingredients and all stages of the production process • Ingredients subject to Part 110 not 111 • Global supply chain • Food/Import safety issues and events (salmonella, melamine, lead in toys, heparin, glycerin) have heightened concern • Cannot test for unknown adulterants or contaminants • Ingredient supplier qualification is critical

  4. GMPs: Subpart E §111.75 • A firm may rely upon a certificate of analysis from its supplier of a component, provided that certain criteria are met which include the following: • The firm first qualifies the supplier by establishing the reliability of the supplier’s CofA through confirmation of the results of the supplier’s tests or examinations; • maintains documentation of how it qualified the supplier; • periodically reconfirms the supplier’s CofA; • quality control personnel review and approve the documentation setting forth the basis for qualification (and requalification) of any supplier.

  5. FDA and supplier qualification • Emphasis in the GMP final rule • Top concern following GMP inspections of large companies • Question from FDA official to four industry trade association: “What are your members doing to qualify their ingredient suppliers?”

  6. Questions & Concerns • What are FDA expectations for vendor qualification? • Will guidance be issued? • What tools are currently available to the industry? ICSB April 16, 2008

  7. SIDI™ Protocol • Developed and maintained by four industry trade associations (CRN, NPA, AHPA, CHPA) • Represents important self-regulatory initiative • Documents revised and posted

  8. Primary Goals of SIDI™ • Assist with DS GMP compliance by serving as a tool for ingredient qualification • Integrate information on raw dietary ingredient sourcing into a voluntary, standardized system – reducing or eliminating the need for questionnaires

  9. Secondary Goals of SIDI™ • Improve the audit process byproviding information in a standardized format for auditors to review in advance • Educate smaller, less experienced firms on regulations, requirements, and industry “best practices”

  10. Results of a SIDI™ survey

  11. Survey Design • E-surveys sent to 279 unique users • Those who accessed the documents from CRN website from Oct 2006 – March 2009 • Additional surveys sent to AHPA, NPA members • Received 71 responses (20% response rate)

  12. Questions • How did you learn about the SIDI protocol? • How important has this initiative become with the publication of the dietary supplement GMP final rule (which emphasizes proper ingredient supplier qualification)? • As an ingredient supplier/distributor/vendor, has your company applied the SIDI protocol to the development of your own ingredient datasheets or information package? • As a finished goods manufacturer, has your company decided to require and/or agreed to accept and/or encouraged your suppliers and vendors to use this approach? • What benefits have you experienced using the SIDI protocol? • How important is it to implementation that regulatory officials, such as FDA, support or endorse SIDI? • Would you recommend the SIDI protocol to another individual or company?

  13. Are suppliers, distributors and/or vendors using the SIDI protocol?* Yes 71% No 29% *Based on 21 firms in this category Are finished goods manufacturers requiring, accepting, and/or encouraging SIDI use?* Yes 69% No 31% *Based on 18 firms in this category

  14. Members of the SIDI™ Working Group

  15. Acknowledgements • IPEC Americas • SIDI™ working group • Haiuyen Nguyen, Research Assistant with CRN

  16. SIDI™: Just one piece of the puzzle • OTHERS • Shared audit system • Quality agreements • Certificates of Analysis

  17. Thank you! Andrew Shao, Ph.D.