Dietary Ingredient Information Protocol (DIIP)

Report
Standardized Information on
Dietary Ingredients
(SIDI™)
A joint trade association initiative to
standardize ingredient information exchange
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Presentation Outline
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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
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Manufacturers use individualized product
questionnaires because they:
 must qualify vendors/suppliers
 cannot audit every vendor
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Questionnaire Challenges
Industry Must Overcome
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Inconsistent and inefficient
Every manufacturer has own individual
format
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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
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Every manufacturer has own individual
format
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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
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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
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SIIP working group’s Standardized
Information on Dietary Ingredients (SIDI™)
Protocol
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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™
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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
Ingredient
suppliers
Manufacturers
Advantages of Using SIDI™
Protocol
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Benefits of standardized ingredient
information is INDUSTRY-WIDE:
Dietary supplement
manufacturers
Ingredient suppliers
Consumers

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Advantages of using SIDI™
Protocol
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Practical and economic advantages
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Hidden costs of current industry
practice:
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Time/potential mistakes/corrections
Significant costs and errors from this activity could
be eliminated!
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Advantages of using SIDI™
Protocol
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For manufacturers:
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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
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For manufacturers:
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Rapid retrieval/interpretation of information
Information is more accessible to FDA
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Facilitates FDA audits (all information is
already assembled)
Facilitates merger/acquisition transitions
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Advantages of using SIDI™
Protocol
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For ingredient suppliers:
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Complete data in standardized format
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Reduced completion time
Increased accuracy of information
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Advantages of using SIDI™
Protocol
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For ingredient suppliers:
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Change control/notification
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Liability risk potentially reduced
Potential for Electronic Data Interchange
(EDI)
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Forms can be made available for download
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Advantages of using SIDI™
Protocol
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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
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Standardized document with change
control, planned updates, and reviews
Broad Scope
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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
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2 separate main sections + glossary
Defines the minimum type and scope of
information that should be covered
Information package vs. questionnaire
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Similar to MSDSs
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Format of DIDS is ingredient supplier’s choice
Minimum topics
Revision history/contact information
Potential for broader usage
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SIDI™ User Guide
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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
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Product Information
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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
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A. Non-Botanical Dietary Ingredients
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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
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B. Botanical Dietary Ingredients
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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
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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
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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
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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
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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
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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
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Industry acceptance
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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
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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
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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???
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