Work Item
ASTM WK73764

New Guide for Process Validation Requirements in the Cannabis Industry

1. Scope

Cannabis sativa is an herbal plant that is being cultivated, harvested, and extracted/refined for use as therapeutic and general consumption at commercial scales. This standard establishes the appropriate elements of process validation enabling cannabis producers to furnish evidence that their process is capable of delivering consistent quality commercial products that meet defined quality attributes and specifications. This includes processes of data collection and evaluation from the design stage through commercial production, establishing scientific evidence that a process is capable of consistently delivering quality products. Process validation is important in that it recognizes that quality cannot be adequately measured solely by in-process and finished-product inspection or testing.


medical marijuana; verification; specifications


Producers are eagerly searching for ways to demonstrate control of their processes to be able to meet consumer demand. However, ensuring that products are consistent, safe, and of established quality parameters for an herbal product currently relies solely on testing of final product. This will provide a robust methodology to allow producers to demonstrate control of their process and minimize risks that are inherent in commercial processes.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: D37.04

Committee: D37

Staff Manager: Jimmy Farrell

Work Item Status

Date Initiated: 08-02-2020

Technical Contact: Rose Mary Aversa

Item: 001

Ballot: D37.04 (22-01)

Status: Will Reballot Item

Item: 001

Ballot: D37 (22-09)

Status: In Balloting