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SIDI™ Working Group Updates—November 2009

JOINT SIDI WORKING GROUP
Progress on Dietary Ingredient Supplier Qualification Initiatives

Next SIDI Working Group in-person meeting Dec. 9—RSVP now

The next meeting will be held on Wednesday, December 9 at CHPA’s office in Washington DC
(http://www.chpa-info.org/aboutchpa/Directions.aspx). 

As with past meetings we will plan to meet from 8AM to 3PM. A detailed agenda will be provided as the date approaches, but at a minimum we will use this as an opportunity for the larger working group to provide feedback to the Subcommittees on any outstanding issues. 

Please RSVP to Andrew Shao (ashao@crnusa.org) or
Haiuyen Nguyen (hnguyen@crnusa.org) if you plan to attend.

Subcommitee Activities

Subcommittee #1: Certificate of Analysis Guidelines

Members

Chair: Anthony Palmieri, DSM

Mike Chansilp, NBTY
Reena Kiriyanthan, NBTY
Elinor Hitchner, Bayer
Reddy Kal, Aaron Industries
Jay Lee, Beijing Gingko Group
Anthony Palmieri (Chair), DSM
Patricia Rohr Albion
Alexa Smith Colorcon
Zhigang Tian, Perrigo
Stephanie  Sigler, Indiana Botanic Gardens
Al Shoemaker, NBTY
Amy Caplette, Nutrilite/Amway
Scott Rosenbush, PL Thomas
YiYi Jing, Natural Factors Nutritional Products
Devon Powell, AHPA

Activities

Certificates of Analysis (COA)

  • Significant progress has been made on the development of the COA Guideline and COA Templates, the latter separated into Botanical and Non-botanical templates.  This Subcommittee has met a total of three times and has reviewed and revised the COA Guideline draft multiple times.
  • The Subcommittee is now looking for approval from the larger Working Group on major items/issues, i.e. important information that is missing or that should be removed.  We can continue to improve the formatting of the documents in the future, but at this time are simply looking to the Working Group to provide broad feedback.
  • The Subcommittee has made little progress on the COA Verification Guideline and will continue to work on that guideline in the coming months.  We hope to provide the Working Group with an update on that progress at the December 9 meeting here in Washington.

Subcommittee #2: Component GMP Guideline

Members
Co-chairs: Kevin Boot, Embria & Mike Bradley, Perrigo

Kristen Blanchard, Nutramax
Kevin Boot (Co-chair), Embria Health Sciences
Mike Bradley (Co-chair), Perrigo
Mike Chansilp, NBTY
Jim Cudahy, Sabinsa Corp
Marvin Herr, Bayer
Reddy Kal, Aaron Industries
Joy Joseph, Joy Quality Management Systems
Kazutoshi Kuroda, Kyowa Hakko
Dave Schoneker, Colorcon
Ed Steele, EAS consulting
Ranga Velagaleti, BASF
Paul Walker, Perrigo
Edward Wyszumiala, NSF
Kay Raman, NBTY
EJ Glaza, Nutrilite/Amway

Activities

Component GMP Guideline

  • This subcommittee has only met once (on 10/29).  Below is a summary of that meeting, which was devoted to determining (a) whether a GMP guideline was the highest priority or if a broader ingredient supplier qualification guideline should be developed first (b) If we proceed in the development of a GMP guideline, on what standard should this be based (c) we learned that IPEC plans to develop a GMP guideline for non-dietary ingredients, i.e. excipients for supplements and discussed how this would affect this Subcommittee’s activities.
  • As is described below, the Subcommittee did feel that a GMP guideline is urgently needed for ingredients, this should be based on the food GMPs (plus necessary additions from the DS GMPs), and that the SIDI Working Group and IPEC should remain in communications as their respective guidelines are developed to minimize the potential for inconsistencies and confusion.
  • Also as a result of the discussion, the Subcommittee is recommending the formation of a fourth subcommittee which would be tasked with the development of a broader Ingredient Supplier Qualification Guideline, much of which would be based on the other guidelines being developed by the SIDI WG Subcommittees.  In light of this discussion, Perrigo’s Mike Bradley has stepped down as Co-chair of Subcommittee #2 and has agreed to serve as Chair of Subcommittee #4 (Supplier Qualification Guideline).
  • Please review the attached matrix provided by Mike Bradley and respond indicating your interest in joining Subcommittee #4.  We will attempt to schedule a meeting with this new subcommittee as soon as we have an adequate number of volunteers.  We can undertake further discussion at the December 9 meeting.

SIDI WG Subcommittee #2 10/29/009 meeting summary

Discussion on reprioritizing

  • Mike Bradley started the meeting by requesting that the Subcommittee step back and reevaluate its priorities.  Mike argued that it would be more valuable to DS manufacturers to have a broad supplier qualification guideline developed first, before proceeding with the development of other specific guidelines, including the Component GMP Guideline.  This stems from the requirement in the DS GMPs that manufacturers must qualify their suppliers, but with little-to-no guidance provided by FDA.  Therefore a broader supplier qualification guideline should be the first priority.
  • Mike also pointed out that there are existing GMP standards to which the industry could refer to for ingredients, e.g. NSF/ANSI, USP and NPA, thus reducing the urgent need for this Subcommittee to develop a separate GMP guideline.
  • Mike provided the group with a matrix where a supplier qualification guideline serves as a broad overview covering many different areas of supplier qualification, including GMP compliance, documentation, certificate of analysis content, CofA verification, etc…
  • The group responded with the caveats that this discussion was held previously (August 6 meeting http://www.crnusa.info/SIDI/PDFs/SIDIWGMtg080609Summary.pdf) and the consensus was to focus on the individual components of supplier qualification, and develop the individual guidelines that would serve as the basis of a broader supplier qualification guideline.  The group also felt that GMPs (for components) are really the focus of any qualification program, and thus development of this guideline remains the first priority.
  • It was also pointed out that the decision to change direction should not be made at the Subcommittee level without the input of the full SIDI Working Group.
  • The consensus of the group was to continue with the development of a GMP guideline for components or ingredients, but to recommend to the larger Working Group that a fourth subcommittee be formed to address in parallel Mike’s suggestion to develop a broader supplier qualification guideline; if this recommendation were to move forward, Mike would step down as Co-chair from this subcommittee to serve as Chair of Subcommittee #4.

Action:

Andrew to send a note to the larger Working Group requesting feedback on the formation of a 4th subcommittee and soliciting volunteers to serve

 IPEC activities and basis of GMP guideline

  • Dave Schoneker (Colorcon/IPEC) updated the group on discussions that have been taking place at IPEC.  The decision has been made to develop a GMP Guideline for non-dietary ingredients (i.e. excipients) that are components of dietary supplements.  This guideline would be a distinct upgrade from the current food GMPs to which food additives, such as excipients for supplements, must be held, but also distinct from IPEC’s GMP Guideline for Pharmaceutical Excipients.
  • IPEC proposes that the SIDI Working Group’s GMP Guideline focus on dietary ingredients, but is also very interested in collaborating with the SIDI Working Group to ensure that any guidelines developed are in sync with each other to minimize the potential for confusion, or perhaps even merge the two into a single guideline.  The Subcommittee discussed the possibility of having IPEC actively participate in our process (and vice-versa) through the formation of a collaborative group, remaining completely separate or staying reasonably informed on each other’s progress.
  • Also discussed was which standard should serve as the basis for these new guidelines.  IPEC will rely on its GMP Guideline for Pharmaceutical Excipients and proposes that the SIDI Working Group do the same.  There was disagreement among the Subcommittee members on this issue.  Some felt that the IPEC Guideline would serve as an appropriate starting point for an ingredient GMP guideline, with the rationale that GMPs are about process controls, not the individual technical nature of the materials being dealt with.  Others felt that the better approach would be to start with the food GMPs and work from there, citing concerns over whether/how botanicals might fit into IPEC’s GMP Guideline.
  • The consensus among the Subcommittee was for the SIDI Working Group and IPEC to remain in communication on these separate guidelines, but not to form a collaborative group (Colorcon’s Dave Schoneker can serve as the obvious liaison) or develop a single guideline, and to start with the food GMPs as the basis of the GMP guideline.
  • The Subcommittee did not discuss thoroughly whether IPEC’s intentions should affect the focus of this GMP guideline, i.e. should the name be altered from “Component” to “Dietary Ingredient” GMP Guideline?

Actions: 

(1) Andrew to provide the Subcommittee with a brief outline that identifies key aspects of the DS GMPs not covered by the food GMPs that would be relevant to ingredient suppliers

(2) The Subcommittee to provide feedback on the focus of this GMP guideline:  Component or Dietary Ingredient?

Subcommittee #3: Communications and Outreach

Members
Chair: Karen Todd, Kyowa Hakko

Jim Cudahy, Sabinsa Corp
Reddy Kal, Aaron Industries
Todd    Norton, AM Todd
Anthony Palmieri, DSM
Karen Todd (Chair), Kyowa Hakko
Marcia Howard, CHPA
Devon Powell, AHPA
Vicki Whitsitt (NPA, for Daniel Fabricant)
           

Activities

Communications and outreach

  • This Subcommittee was formed to properly address communications and marketing aspects of the Working Group’s efforts.  The launch and continued maintenance of the SIDI protocol lacked this kind of strategic input from communications/marketing and SIDI’s awareness and use has suffered as a consequence.
  • This Subcommittee has been tasked with development and execution of both short and long-term strategies to build awareness and ensure adoption and implementation of the guidelines developed by this working group.  The group has met several times by conference call.
  • In the short-term, as the other subcommittees work to develop supplier qualification guidelines, this group is focused on building awareness and use of the SIDI protocol (the first guideline developed).  Tactics include promoting SIDI’s use through the obvious channels and mediums (trade shows, trade print media) and also via the online community.
  • Longer-term strategies include leveraging GMP compliance requirements and requirements from food safety legislation to help facilitate widespread adoption of subsequent guidelines and the potential shared audit system.
  • The group has consulted members of the trade media to assist with some of the outreach and communications activities.
  • There are SIDI promotional activities planned in conjunction with the upcoming Supply Side West trade show in Las Vegas (Nov 11-13)

A one page description of SIDI will be available for handout at two of the Education Sessions (see below).  Those of you attending the show, please show your support by attending one or both of these sessions.  We will try to provide Working Group members with some of these one-pagers to hand out at your respective booths.

http://www.supplysideshow.com/west/2009/nutrition_track1.html

Wednesday, November 11 • 2-2:50pm

Location: Congress Center, Casanova 601, Level 1

How to Prepare for and Survive a Dietary Supplement GMP Audit
The Nutrilite facility of Amway Global was one of the first facilities to be audited for compliance of the new current Good Manufacturing Practices (cGMP) for Dietary Supplements by the Food and Drug Administration (FDA). Attend this session to learn how Amway Global prepared for the audit and listen as insight is provided on what to expect during the multi-day audit.

Speakers:
Amy Caplette, quality assurance supervisor group leader, Amway Global Nutrilite Products
Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, Council for Responsible Nutrition

Thursday, November 12 • 11-11:50am
Location: Congress Center, Casanova 601, Level 1

Qualifying Dietary Supplement Ingredient Suppliers: FDA's Perspective
A major component of meeting the Food and Drug Administration's (FDA) new dietary supplement GMP (good manufacturing practice) regulations is the need to "qualify" suppliers of ingredients used in dietary supplements. If a manufacturer wants to use ingredient suppliers' Certificate of Analysis (COA) for GMP compliance purposes, the ingredient supplier must be "qualified." This presentation will provide information for dietary supplement manufacturers and ingredient suppliers on FDA's expectation of the types of information that would be collected when a supplier is "qualified."

Speaker: Vasilios H. Frankos, Ph.D., director, Division of Dietary Supplement Programs, Food and Drug Administration