SupplySide East, April 28, 2009Council for Responsible Nutrition Ingredient Supplier Qualification Implementation of the SIDI™ protocol

SupplySide East, April 28, 2009Council for Responsible Nutrition 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” - ????

SupplySide East, April 28, 2009Council for Responsible Nutrition 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

SupplySide East, April 28, 2009Council for Responsible Nutrition 4 GMPs: Subpart E § 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.

SupplySide East, April 28, 2009Council for Responsible Nutrition 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?”

SupplySide East, April 28, 2009Council for Responsible Nutrition ICSB April 16, 2008 Questions & Concerns What are FDA expectations for vendor qualification? Will guidance be issued? What tools are currently available to the industry?

SupplySide East, April 28, 2009Council for Responsible Nutrition 7 SIDI™ Protocol Developed and maintained by four industry trade associations (CRN, NPA, AHPA, CHPA) Represents important self-regulatory initiative Documents revised and posted

SupplySide East, April 28, 2009Council for Responsible Nutrition 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

SupplySide East, April 28, 2009Council for Responsible Nutrition 9 Secondary Goals of SIDI™ Improve the audit process by providing information in a standardized format for auditors to review in advance Educate smaller, less experienced firms on regulations, requirements, and industry “best practices”

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition Results of a SIDI™ survey

SupplySide East, April 28, 2009Council for Responsible Nutrition 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)

SupplySide East, April 28, 2009Council for Responsible Nutrition 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?

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition Are suppliers, distributors and/or vendors using the SIDI protocol?* Yes 71% No 29% Are finished goods manufacturers requiring, accepting, and/or encouraging SIDI use?* Yes 69% No 31% *Based on 21 firms in this category *Based on 18 firms in this category

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition

SupplySide East, April 28, 2009Council for Responsible Nutrition Members of the SIDI™ Working Group

SupplySide East, April 28, 2009Council for Responsible Nutrition Acknowledgements IPEC Americas SIDI™ working group Haiuyen Nguyen, Research Assistant with CRN

SupplySide East, April 28, 2009Council for Responsible Nutrition SIDI™: Just one piece of the puzzle OTHERS Shared audit system Quality agreements Certificates of Analysis

SupplySide East, April 28, 2009Council for Responsible Nutrition Thank you! 26 Andrew Shao, Ph.D.