No universally accepted Standards for Cannabis manufacturing.

There are no universally accepted Standards or Current Good Manufacturing Practices for Cannabis Manufacturing. Guidelines such as 21 CFR parts 210 and 211, 21 CFR parts 110 and 111, 21 CFR part 112, ICH Q7, FOCUS Standards, American Herbal Products Association, and Americans for Safe Access are applicable, but have not been fully adopted by the cannabis industry.

There are no shortages on standards to choose from. However, ASTM International (American Standards for Testing and Materials) is reviewing all such standards, and generating what will be international standards for cannabis Good Manufacturing Practices. If you are not familiar, check out ASTM D37 Cannabis Standards Committee to get an idea of what the future of Cannabis Standards and Good Manufacturing Practices will look like.

FDA and the Risk Based Approach.

The Food and Drug Administration recommends cGMPs be applied on a “Risk-Based Approach.” This offers a manufacturer the flexibility to operate within guidelines, or make scientifically valid studies that prove the application of cGMPs is not necessary. For this reason, manufacturers should take this approach to their GMP Cannabis Manufacturing activities.

Cannabis manufacturing is stricken with risks. Cultivation problems often arise due to poorly engineered process, that never took account of the risks. Simple applications of risk management through Failure Mode and Effect Analysis are used every day in manufacturing, and considerably change the way one makes decision while engineering inefficiencies and risks our of a process. These tools, while foreign to most, are simple to use and deploy.

Action you can take:

Consider your customer demographics. What appeals to them? Do FDA cGMPs meet their needs, or are FOCUS Standards their preference?

This takes some careful consideration. Going with the FDA cGMPs may confine your operations and how you manufacture, while FOCUS Standards, et al, may provide operational flexibility and adaptability.

Learn about Failure Mode and Effect Analysis, and identify the biggest risks to your organization’s bottom line.

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