[MPWG] Transparency clarifications

[Steven Dentali, Ph.D.]

A certificate of analysis is just that, a certification of analytical 
results to determine if the material analyzed meets predetermined 
specifications. Specifications are part of standardization, which is the 
process represented by the documentation and controls needed to insure a 
reasonably consistent product (it is not merely assuring the amount of a 
chemical standard in an extract, active or not-AHPA has guidance 
documents that explain this in gory detail).

Purchasers have, or should have, product specifications. The way to 
determine if specifications are met is to evaluate (sensory or 
otherwise) the material. The CoA is generated to show that this was done 
and to provide the actual test results. Ways to prove identity can be 
part of specifications and is often a requirement for crude botanical 
material before reaching a manufacturer. It is often appropriately 
treated as a separate matter because botanical identity is a matter of 
taxonomy not chemistry.

The issue of who generates a CoA hinges on reliability only. It doesn't 
matter where the analysis is done as long as steps have been taken to 
ensure that the results are reliable. As to the earlier question of 
quality; quality is what you define it to be. Developing product 
specifications, and ensuring they are met, is one way to do this.

-- 
Steven Dentali, Ph.D.
VP – Scientific and Technical Affairs
American Herbal Products Association
8484 Georgia Avenue, Suite 370
Silver Spring, MD  20910
301.588.1171 x 103
Fax: 301.588.1174
www.ahpa.org



Patricia_DeAngelis at fws.gov wrote:

>2. Also, isn't there a role for the Certificates of Analysis (COA) in all
>of this?
>
>A COA is generated (all the time?) at some point between being dug out of
>the ground (or picked, cut, etc.) and reaching the manufacturer.  The
>information on these COAs already help to identify the quality and source
>of the material.  I understand that there is some discussion as to when and
>who should be responsible for generating the COA.  Perhaps my industry
>colleagues will comment on this.
>
>But, I'd also like to hear from you with respect to a broader use for the
>COA - in commerce, for instance.   From a CITES perspective, a big
>difficulty comes in trying to identify materials in trade.  When a dry,
>brown powder comes to a port/border, the COA could serve as the
>identification tool.  I mean, the COA is already being generated, couldn't
>it be tweaked a bit to fit this need?
>  
>