Ingredient Supplier Qualification

1
Ingredient Supplier Qualification

• Implementation of the SIDI protocol

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 - ????
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

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 suppliers
  CofA through confirmation of the results of the
  suppliers tests or examinations
• maintains documentation of how it qualified the
  supplier
• periodically reconfirms the suppliers CofA
• quality control personnel review and approve the
  documentation setting forth the basis for
  qualification (and requalification) of any
  supplier.

5
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?

6
Questions Concerns

• What are FDA expectations for vendor
  qualification?
• Will guidance be issued?
• What tools are currently available to the
  industry?

7
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.inf
  o/SIDI/

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

9
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

10
(No Transcript)
11
(No Transcript)
12
(No Transcript)
13
Results of a SIDI survey
14
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)

15
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?

16
(No Transcript)
17
(No Transcript)
18
(No Transcript)
19
Are suppliers, distributors and/or vendors using
the SIDI protocol?
Yes 71
No 29
Based on 21 firms in this category
Are finished goods manufacturers requiring,
accepting, and/or encouraging SIDI use?
Yes 69
No 31
Based on 18 firms in this category
20
(No Transcript)
21
(No Transcript)
22
(No Transcript)
23
Members of the SIDI Working Group
24
Acknowledgements

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

25
SIDI Just one piece of the puzzle

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

26
Thank you!
Andrew Shao, Ph.D. ashao_at_crnusa.org
www.crnusa.org