AOAC CASP Meeting - MYM 2020

Validation Guidance

• An initial and important stage in cannabis testing is preparation of a homogeneous sample of the plant material. Detailed and complete procedures for reproducible preparation of test samples from the plant material must be addressed during method validation and those data must be included in the method validation submission. • Validation should include data demonstrating performance for various samples with moisture levels at different points within the method range, with some samples falling in the lower part of the range and some in the higher part of the NMT 15% range. Most dried hemp samples are expected to contain 4 ‐ 12% moisture.

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Comments Submitted

Comment Type

Comment

Proposed Solution

Technical

Line 48  ‐ 50 (Method Performance Requirements) and Line 104 (Method performance requirements table) How was repeatability performance requirement of the method at < or = 2% RSD determined? This requirement seems relatively small considering the matrix scope. Was this requirement determined using a single lab method study using one or more common moisture method(s)? If not, was this requirement based upon another standard test method for the same or similar matrix scope? if so, what standard test method was used? Line 28, Quantitative method description (lines 29 ‐ 31) could be improved in regard to clarity

I have no proposed change to the repeatability performance requirement at this time. I simply would like to understand how the repeatability requirement for this SMPR was determined.

Editorial

Line 29  ‐ 31 This method covers analytical techniques that are suitable for moisture determination on plant based material. These techniques may include direct measurement such as thermogravimetric mass loss measurement, volumetric or coulometric titration and indirect measurement such as absorbance or impedance of the sample

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