Setting Standards For Cannabis As An Investigational Medicinal Product

Cannabis and related compounds are being used in a range of research studies. This has prompted the U.S. Food and Drug Administration (FDA) to issue draft guidance on sources of cannabis, quality control for the release of cannabis products, and methods of tetrahydrocannabinol (THC) calculation, in order to assess levels of the psychoactive compound. Assessing quality for cannabis products manufactured within GMP environments is important and over the past few years, solvent residues (in the finished product), pathogenic microorganisms, and toxic heavy metals (such as from fertilizers) have each presented contamination risks and posed regulatory challenges. With the timing of the document itself, guidance is overdue, but the issuing of the document became complicated due to different positions as to the legal status of the drug at state and federal level.

This article looks at the main points in the guidance and the requirements for quality control testing and assessing the purity of the end product.

The reference is:

Sandle, T. (2020) Setting Standards For Cannabis As An Investigational Medicinal Product, IVT Network, at: https://www.ivtnetwork.com/article/setting-standards-cannabis-investigational-medicinal-product

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)