AOAC SPSFAM Meeting Book 9-24

Memo

From:

AOAC Cannabis Working Group

Date:

August 30, 2017

RE:

Clarification on Validation Guidance for SMPRs 2017.001 and 2017.002

1. The Cannabis Working Group has been made aware of the expense for certified reference materials for cannabinoids. Method developers may choose to provide accuracy validation data using CRMs for the lower and middle ranges as specified in SMPRs 2017.001 and/or 2017.002. Method developers may use their own in house materials for accuracy but must provide traceability to SI or NMI (see Annex F of Appendix F of OMA). 2. Method developers are expected to provide precision (RSDr) data for all three ranges specified in the SMPR. Method developers may use in house prepared reference materials as per Annex F of Appendix F of OMA to determine precision.

3. Very well characterized hemp material may be used as a surrogate for low level cannabis materials until cannabis standard materials are available.

4. The exceptions listed in this Clarification of Validation Guidance memo could be accepted for First Action Official Methods of Analysis approval. However, it is expected that method developers shall submit accuracy data at all concentrations listed in the SMPRs 2017.001 and/or 2017.002 using certified reference materials for FINAL ACTION status.