The American Herbal Products Association held a seminar providing industry with practical and targeted information on how to meet the regulatory requirements concerning two of the more nebulous aspects of the dietary supplement GMP regulations (21 CFR 111): establishing identity and vendor qualification (21 CFR 111.75).
Tony Young, AHPA General Counsel and partner with the DC law firm Kleinfeld, Kaplan & Becker, was one of the presenters at the seminar, "The regulations at best provide a basic outline for how to meet the requirements – very little detail. But they clearly require that an identity test be performed on all dietary ingredients and that all other components be identified through tests or examinations." The GMP requires manufacturers who wish instead to rely on component vendors Certificate of Analysis (COA), to do the following:
(A) You first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations;
(B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations;
(C) You maintain documentation of how you qualified the supplier;
(D) You periodically re-confirm the supplier's certificate of analysis; and
(E) Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.
Young, along with several of the other presenters, stressed the importance of entering into vendor contracts and establishing expectations and guidelines for any critical aspects of the vendor/supplier or vendor/3rd party lab partnership. "Having agreements that outline what will happen when something is Out Of Spec, for example, is a necessary business tool," said Young. Margaret King, QA/QC Senior Director at Metagenics, echoed Young's thoughts during her presentation titled, How to Qualify a 3rd Party Laboratory, "You absolutely need to have a laboratory service contract when it comes to using a 3rd party lab for doing your ID work, and it needs to include items such as sample custody, establishing testing methods to be used, confidentiality agreements, and more in order to properly establish a good working partnership and meeting expectations."
AHPA Chief Science Officer, Steven Dentali, Ph.D., discussed the regulations and general information regarding establishing identity, and provided participants with information on the available methods and giving advice on determining which to use. He also highlighted the difference between "validated" and "scientifically valid," the latter of which is required in the regulations. "Clearly this has been a source of confusion to many businesses, 'scientifically valid' simply means a method of analysis that is 'fit for purpose' – or does what it is intended to do. So in the case of establishing identity, the tests chosen would need to be ones that – for example with chamomile – establish the identity of chamomile rather than something else altogether. Officially validated methods are scientifically valid, but scientifically valid methods don't have to go through an official validation process to work for their intended use," said Dentali.
Rupa Das, VP of Quality at BI Nutraceuticals and Angie Kwong, Quality Manager with Traditional Medicinals discussed vendor qualification from the perspectives of the supplier and manufacturer. Ms. Das provided useful anecdotal information in regards to supplier qualification, while Ms. Kwong offered practical information on factors to consider when developing a vendor qualification program. Participants were also encouraged to visit the joint industry SIDI working group website, in which AHPA is an active participant, at http://www.vendorqualification.com/, where several items of interest in regards to the topic would be available or available soon, including a COA Guideline and templates, as well as an overall vendor qualification "matrix."
The seminar, which included a Q&A session at the end, will be available in the coming weeks on the AHPA website in the online bookstore. It will include an audio recording of the event, unedited transcript, as well as all presentations and participant documentation. For more details, please contact Devon Powell, AHPA Chief Operations Officer, at [email protected] or 301.588.1171 x102.