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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.