SPSFAM Meeting eBook March 2017

3/9/2017

Comments Submitted

4. There should be some kind of information to help an ERP understand the  homogeneity issues that are possible with these plants. 1. They are  resinous, cannabinoids are concentrated in the resin, which can clump  during grinding. 2. Between flower variation can be high, grinding multiple  flowers can impact the homogeneity. 3. Grinding can introduce heat,  which will cause degradation of cannabidiolic acids into neutral forms,  resulting in less accurate results. Grinding would be the best option for  homogeneous samples, but in some cases there are issues with clumped  resin, highly variable samples and additional grinding would impact the  results and lead to inaccurate data. ‐ There should be a comment stating that the method performance should be  demonstrated with homogeneous samples, and note that in some cases materials 

may not meet these criteria due to inherent variation.  Action: Amended Section 8:  Validation Guidance

5. Tables 2 and 3 should identify which  cannabinoids apply ‐ Propose the following changes to Tables 2  and 3 headers:  ”These performance  requirements apply only to the cannabinoids  in Table 1a”

 Action:  Amendments per recommendation.

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