SupplySide East, April 28, 2009 Council for Responsible Nutrition

Ingredient Supplier Qualification

Implementation of the SIDI™ protocol

SupplySide East, April 28, 2009 Council 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, 2009 Council 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, 2009 Council for Responsible Nutrition 4

GMPs: Subpart E §111.75• 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, 2009 Council 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, 2009 Council for Responsible NutritionICSB April 16, 2008

Questions & Concerns

• What are FDA expectations for vendor qualification?

• Will guidance be issued?• What tools are currently available to the

industry?

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SIDI™ Protocol • Developed and maintained by four industry

trade associations (CRN, NPA, AHPA, CHPA)• Represents important self-regulatory initiative• Documents revised and posted

http://www.crnusa.info/SIDI/

SupplySide East, April 28, 2009 Council 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

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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, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

Results of a SIDI™ survey

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

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

Are suppliers, distributors and/or vendors using the SIDI protocol?*

Yes71%

No29%

Are finished goods manufacturers requiring, accepting, and/or

encouraging SIDI use?*

Yes69%

No31%

*Based on 21 firms in this category

*Based on 18 firms in this category

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SupplySide East, April 28, 2009 Council for Responsible Nutrition

Members of the SIDI™ Working Group

SupplySide East, April 28, 2009 Council for Responsible Nutrition

Acknowledgements

• IPEC Americas• SIDI™ working group• Haiuyen Nguyen, Research Assistant with

CRN

SupplySide East, April 28, 2009 Council for Responsible Nutrition

SIDI™: Just one piece of the puzzle

OTHERS• Shared audit system• Quality agreements• Certificates of Analysis

SupplySide East, April 28, 2009 Council for Responsible Nutrition

Thank you!

26

Andrew Shao, Ph.D. ashao@crnusa.org

www.crnusa.org