Work Item
ASTM WK80450
New Specification for Quality Management System Requirements for Cannabis and Hemp Operations
1. Scope
This specification presents requirements for 17 core elements of an effective quality management system (QMS). A brief description of each QMS element is provided in section 5. Related ASTM guides or practices for the elements of a quality management system are referenced.
Keywords
cannabis; CAPA; change management; continuous improvement; deviations; hemp; IQ/OQ/PQ; marijuana, consumer safety; qualifications; quality control; quality management system, document control; process control; recall; removal; SOPs maintenance; training; validation; verification
Rationale
The objective of this standard is to define basic criteria for each of the 17 elements of a quality management system. States and nations are increasingly adopting more elements of QMS and GMP, good manufacturing practice. This standard can be used to 1) inform state and national regulatory agencies, 2) provide third-party certification bodies with quality related specifications for Cannabis operations, 3) guide cannabis processors and manufacturers by providing actionable requirements that they can implement to prepare for future regulations and certification or voluntarily adopt because it is good business practice, and 4) inform the writing of the other related D37.02 guides that are identified to be created.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 01-08-2022
Technical Contact: Ed Nodland
Item: 001
Ballot: D37.02 (22-01)
Status: Negative Votes Need Resolution