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Standardized Information on Dietary Ingredients (SIDI™)

Standardized Information on Dietary Ingredients (SIDI™). A joint trade association initiative to standardize ingredient information exchange. Presentation Outline. Members of SIIP working group Current industry practice Industry challenges to overcome Goals/advantages of SIDI™

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Standardized Information on Dietary Ingredients (SIDI™)

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  1. Standardized Information on Dietary Ingredients(SIDI™) A joint trade association initiative to standardize ingredient information exchange SIDI™ ppt V2.0 1-01-08

  2. Presentation Outline • Members of SIIP working group • Current industry practice • Industry challenges to overcome • Goals/advantages of SIDI™ • Planned process/format • Next steps SIDI™ ppt V2.0 1-01-08

  3. Members of the Standardized Information on Dietary Ingredients (SIDI) Working Group SIDI™ ppt V2.0 1-01-08

  4. Current Industry Practice • Manufacturers use individualized product questionnaires because they: • must qualify vendors/suppliers • cannot audit every vendor SIDI™ ppt V2.0 1-01-08

  5. Questionnaire Challenges Industry Must Overcome • Inconsistent and inefficient • Every manufacturer has own individual format • Difficult for vendor to complete quickly/accurately • Questions may not apply to ingredient(s) of concern • Require stamps/signatures: what do these really mean? SIDI™ ppt V2.0 1-01-08

  6. Questionnaire Challenges Industry Must Overcome • Every manufacturer has own individual format • Vendors receive too many questionnaires to complete • Change control practically impossible • Questionnaires often sent to distributors • Most common response: N/A! SIDI™ ppt V2.0 1-01-08

  7. Questionnaire Challenges Industry Must Overcome • Manufacturer sends out and receives back 100 questionnaires of 50+ pages each: • Who reviews all this information? • How much actual information is provided? • How is the information judged, stored, retrieved? • What about change control? SIDI™ ppt V2.0 1-01-08

  8. The Proposed Solution • SIIP working group’s Standardized Information on Dietary Ingredients (SIDI™) Protocol • Provides the basis for suppliers to develop their own dietary ingredient data sheets (DIDS)to be sent to manufactures in lieu of questionnaires • Based on the Excipient Information Protocol (EIP) developed by IPEC SIDI™ ppt V2.0 1-01-08

  9. Primary Goals of the SIDI™ • Enhance information management between dietary ingredient suppliers and dietary supplement manufacturers by providing standards for the exchange of data. • Integrate information on raw dietary ingredient sourcing into a voluntary, standardized system - eliminating the need for a questionnaire SIDI™ ppt V2.0 1-01-08

  10. Ingredient suppliers Manufacturers Optimizing information exchange between ingredient suppliers and manufactures, benefiting industry and consumers

  11. Advantages of Using SIDI™ Protocol • Benefits of standardized ingredient information is INDUSTRY-WIDE: • Dietary supplement manufacturers • Ingredient suppliers • Consumers SIDI™ ppt V2.0 1-01-08

  12. Advantages of using SIDI™ Protocol • Practical and economic advantages • Hidden costs of current industry practice: • Time/potential mistakes/corrections Significant costs and errors from this activity could be eliminated! SIDI™ ppt V2.0 1-01-08

  13. Advantages of using SIDI™ Protocol • For manufacturers: • Consistent information from multiple suppliers and across product lines • Reduction/reallocation of costs/resources • Changecontrol SIDI™ ppt V2.0 1-01-08

  14. Advantages of using SIDI™ Protocol • For manufacturers: • Rapid retrieval/interpretation of information • Information is more accessible to FDA • Facilitates FDA audits (all information is already assembled) • Facilitates merger/acquisition transitions SIDI™ ppt V2.0 1-01-08

  15. Advantages of using SIDI™ Protocol • For ingredient suppliers: • Complete data in standardized format • Reduced completion time • Increased accuracy of information SIDI™ ppt V2.0 1-01-08

  16. Advantages of using SIDI™ Protocol • For ingredient suppliers: • Change control/notification • Liability risk potentially reduced • Potential for Electronic Data Interchange (EDI) • Forms can be made available for download SIDI™ ppt V2.0 1-01-08

  17. Advantages of using SIDI™ Protocol • For consumers: • Increased standardization of any process has potential to reduce risk of error • More organized system of vendor qualification could increase safety/quality of products SIDI™ ppt V2.0 1-01-08

  18. SIDI™ Protocol Contents • Scope and purpose of the SIDI™ Protocol • Formatting information • Section-by-section evaluation of the SIDI™ document • Dietary ingredient data sheets (DIDS) • Interactive definitions and glossary SIDI™ ppt V2.0 1-01-08

  19. Highlights of the SIDI™ Protocol • Standardized document with change control, planned updates, and reviews • Broad Scope • developed by members of four industry trade associations with the goal of obtaining industry-wide acceptance • Use is entirely voluntary and is not enforceable • Has been provided to FDA for comment SIDI™ ppt V2.0 1-01-08

  20. SIDI™ Format • 2 separate main sections + glossary • Defines the minimum type and scope of information that should be covered • Information package vs. questionnaire • Format of DIDS is ingredient supplier’s choice • Similar to MSDSs • Minimum topics • Revision history/contact information • Potential for broader usage SIDI™ ppt V2.0 1-01-08

  21. SIDI™ User Guide • SIDI User Guide • Description of SIDI • How to obtain the document • Tips on use and application SIDI™ ppt V2.0 1-01-08

  22. SIDI™ Protocol SIDI™ ppt V2.0 1-01-08

  23. Part I • Product Information • Intended for non-botanical & botanical ingredients • Important physical, manufacturing and regulatory information specific to the ingredient • Intended to facilitate the use of the ingredient in finished products SIDI™ ppt V2.0 1-01-08

  24. Product Information • A. Non-Botanical Dietary Ingredients • Section 1 – Product Information • Section 2 – Manufacturing Information • Section 3 – Physical/Chemical Information • Section 4 – Labeling Information • Section 5 – Regulatory Information • Section 6 – Miscellaneous Product Information • Section 7 – Revisions • Section 8 – Contact Information SIDI™ ppt V2.0 1-01-08

  25. Product Information • B. Botanical Dietary Ingredients • Section 2 – Botanical Manufacturing Information • Section 3 – Physical/Chemical Information • Section 4 – Labeling Information • Section 1 – Botanical Product Information • Section 5 – Regulatory Information • Section 6 – Miscellaneous Product Information • Section 7 – Revisions • Section 8 – Contact Information SIDI™ ppt V2.0 1-01-08

  26. Part II • Site Quality Overview • Tool to assist in evaluating the manufacturing practices and quality systems of ingredient suppliers • Intended to address the foundation of the requirements and not all of the details • Site specific SIDI™ ppt V2.0 1-01-08

  27. Site Quality Overview • Section 1 – Site Overview • Section 2 – Evidence of Compliance • Section 3 – cGMP Compliance Details • Section 4 – Additional Information • Section 5 – Revisions • Section 6 – Contact Information SIDI™ ppt V2.0 1-01-08

  28. Glossary • Comprehensive glossary • Contains a comprehensive list of terms, compendia, regulations, authoritative bodies • Definitions, web site links • Hyperlinked to terms in the body of the document SIDI™ ppt V2.0 1-01-08

  29. Uses of SIDI • Point of differentiation for quality focused ingredient suppliers • Serves as “pre-audit” assisting manufacturers with vendor qualification and GMP compliance • NDI notification • International product registration SIDI™ ppt V2.0 1-01-08

  30. Future Developments • Periodic surveys of SIDI™ users • Continued emphasis at industry trade shows and in trade publications • Globalization SIDI™ ppt V2.0 1-01-08

  31. Accessing the SIDI™ Accessible free of charge at: www.ahpa.org; www.chpa-info.org; www.crnusa.org; www.naturalproductsassoc.org • Questions can be submitted to AHPA, CHPA, CRN or Natural Products Association • Will be used as the basis for updates to the Protocol SIDI™ ppt V2.0 1-01-08

  32. Challenges to Implementation • Industry acceptance • Each manufacturer “attached” to their own system • Ingredient suppliers must maintain sensitivity to customers special requests (customer service) • Both suppliers and manufacturers must remain current on global requirements SIDI™ ppt V2.0 1-01-08

  33. Summary • Current industry challenges • Goal of SIDI™ - To optimize information exchange between ingredient suppliers and manufacturers, benefiting industry and consumer SIDI™ ppt V2.0 1-01-08

  34. Special Acknowledgements • Paul Bolar, Pharmavite • Dave Schoneker & Alexa Smith, Colorcon, IPEC • Steven Dentali, AHPA • Marcia Howard, CHPA • Dan Fabricant, NPA • Andrew Shao, CRN SIDI™ ppt V2.0 1-01-08

  35. Questions??? SIDI™ ppt V2.0 1-01-08

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