Work Item
ASTM WK83754
New Guide for Guide for Change Control in the Cannabis Industry
1. Scope
1.1 This guide applies to the manufacture of cannabis/hemp products for human and animal use
1.2 This guide defines change control and how change is managed within the Quality Management System.
Keywords
temporary change, process improvements, notification of change
Rationale
Standard is needed as the change control is pertinent to all applicable FDA Good Manufacturing Practices. It also ensures that change is managed in order to prevent risk and negative impact on product quality.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 10-13-2022
Technical Contact: Darcie Moran
Item: 001
Ballot: D37.02 (23-02)
Status: Negative Votes Need Resolution