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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.
Keywords
medical marijuana; verification; specifications
Rationale
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.
