W. CONSHOHOCKEN, Pa. – ASTM International’s cannabis committee (D37) has approved two complimentary standards that address quality management systems (QMS) and good manufacturing practices (GMPs).
New standard D8556 provides a concise set of QMS requirements that can be used as the basis for any/all of the following: gap assessments, internal and external audits, training programs, certification programs, and implementation checklists.
“This standard was written to provide a definitive and authoritative list of QMS requirements to produce internal assessment and certification audit programs,” says ASTM member Ed Nodland. “This standard defines what is required, while the individual guides address why and how to implement the elements of an operation’s QMS.”
Nodland notes that the new standard will have several uses:
- Cannabis businesses will be able to perform assessments to identify and address gaps in quality practices;
- Regulators can review regulations for gaps, and;
- Certification bodies can perform QMS certification audits based on industry consensus requirements.
- Consumers will be able to trust that products purchased from a certified operation can be trusted to be consistent from purchase to purchase.
The second new D37 standard, D8557, will provide guidance for developing and implementing GMPs for the manufacture of cannabis/hemp-containing edibles, dietary supplements, topicals, and inhaled products for human use.
“This new standard is a practical roadmap on what it means to have GMPs for companies that produce various kinds of cannabis products, “says ASTM member Steven Gendel. “This is particularly important for producers that operate in jurisdictions where local regulations are incomplete or unclear.”
Gendel says that D8557 will help ensure a cannabis-containing product is made in an environment that keeps it safe and high-quality.
“Together D8556 and D8557 provide much-needed consistency across many jurisdictions,” says Nodland. “Multi-regional operations are faced with a wide variety of regulations. As these two standards gain acceptance and adoption by the industry and regulators, internationally accepted practices will emerge.”
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