Standardized Information on Dietary Ingredients SIDI

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Standardized Information on Dietary
Ingredients(SIDI)

• A joint trade association initiative to
  standardize ingredient information exchange

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Presentation Outline

• Members of SIIP working group
• Current industry practice
• Industry challenges to overcome
• Goals/advantages of SIDI
• Planned process/format
• Next steps

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Members of the Standardized Information on
Dietary Ingredients (SIDI) Working Group
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Current Industry Practice

• Manufacturers use individualized product
  questionnaires because they
• must qualify vendors/suppliers
• cannot audit every vendor

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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?

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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!

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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?

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The Proposed Solution

• SIIP working groups 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

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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

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Optimizing information exchange between
ingredient suppliers and manufactures,
benefiting industry and consumers
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Advantages of Using SIDI Protocol

• Benefits of standardized ingredient information
  is INDUSTRY-WIDE
• Dietary supplement manufacturers
• Ingredient suppliers
• Consumers

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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!

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Advantages of using SIDI Protocol

• For manufacturers
• Consistent information from multiple suppliers
  and across product lines
• Reduction/reallocation of costs/resources
• Change control

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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

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Advantages of using SIDI Protocol

• For ingredient suppliers
• Complete data in standardized format
• Reduced completion time
• Increased accuracy of information

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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

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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

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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

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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

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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 suppliers choice
• Similar to MSDSs
• Minimum topics
• Revision history/contact information
• Potential for broader usage

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SIDI User Guide

• SIDI? User Guide
• Description of SIDI
• How to obtain the document
• Tips on use and application

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SIDI Protocol
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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

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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

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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

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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

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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

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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

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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

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Future Developments

• Periodic surveys of SIDI users
• Continued emphasis at industry trade shows and in
  trade publications
• Globalization

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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

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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

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Summary

• Current industry challenges
• Goal of SIDI - To optimize information exchange
  between ingredient suppliers and manufacturers,
  benefiting industry and consumer

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Special Acknowledgements

• Paul Bolar, Pharmavite
• Dave Schoneker Alexa Smith, Colorcon, IPEC
• Steven Dentali, AHPA
• Marcia Howard, CHPA
• Dan Fabricant, NPA
• Andrew Shao, CRN

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Questions???