1 / 35

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™

karah
Download Presentation

Standardized Information on Dietary Ingredients (SIDI™)

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. 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

More Related