Harmonizing BCC method validation requirements with AOAC and FDA guidelines

Posted by

Analytical Cannabis

As cannabis legalization progresses around the world, the regulation of cannabis products by government agencies is also growing. The requirement for laboratory testing of cannabis products for potency and potentially harmful contaminants is now a common aspect of cannabis regulatory regimes. However, in such a newly regulated industry with an illicit past, questions often circulate about the reliability of laboratory testing. In regulated industries, analytical methodologies used to assess product purity and quality are typically required to be validated prior to their use for testing samples. Method validation is defined as the process of establishing documented evidence that demonstrates or confirms that the performance characteristics of a method are suitable for its intended purpose. In California, the Bureau of Cannabis Control (BCC) requires testing laboratories to validate the methods they use according to specific FDA and AOAC guidelines. In this talk I will discuss our (IAS’s) interpretation and application of these guidelines to validate methods, harmonizing the BCC regulations and guidelines with those of the FDA and AOAC, and the challenges laboratories face when validating methods for cannabis products because they contain schedule I drugs.