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APPLICATION OF GMP IN THE CANNABIS INDUSTRY

ABSTRACT Many European Union (EU) countries have legalized or decriminalized the medical use of cannabis to some degree. The advent of broad acceptance of medical cannabis as public opinion shifts in the EU is driving the need for the cannabis industry to implement strict regulatory controls on the production of cannabis products. There is therefore a shift to implementation of GMP (Good Manufacturing Practices) in the cannabis space, most notably in Canada, where medical cannabis production has been legal since 2001 but regulated to a lesser extent than the GMP standard. Due to the lack of regulatory harmonization in the US, this shift to GMP standards for production is expected to impact the US market when medical cannabis laws become regulated federally. The interfaces of medical … [Read more...] about APPLICATION OF GMP IN THE CANNABIS INDUSTRY

Developing The Preventative Control Plan, Part II

The Preventive Control Plan (PCP) development process is a long and extensive process requiring expertise of personnel from different departments and commitment by senior management for its effective implementation and continued success. The development process starts by assembling a team of Subject Matter Experts from different departments and levels in the organization who are knowledgeable in their areas of work and bring in that knowledge to table. Participation from all departments and tiers in the organization is important to ensure the robustness of the PCP, foster employee cooperation which forms the foundation for a well-rounded Preventive Control Plan. After the team is formed, the next step is to develop SOPs for addressing elements of a PCP. This part is similar to … [Read more...] about Developing The Preventative Control Plan, Part II

Reconsidering International Cannabis Policies: Vote on World Health Organization recommendations delayed

On February 25, 2019 the United Nations Commission on Narcotic Drugs (CND) delayed the vote on recommendations by the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD) to reschedule cannabis under international conventions. The vote on these recommendations was proposed to occur during the CNDs 62nd session in Vienna, Austria in March. In late January 2019, the WHO ECDD proposed recommendations to the CND that cannabis be rescheduled from the Single Convention on Narcotic Drugs 1961 (1961 Convention) and the Convention on Psychotropic Substances 1971 (1971 Convention). With these recommendations, the cannabis community is overwhelmed with much fervor and excitement. But what does this all mean? Conventions and Controls The CND is a policy making body … [Read more...] about Reconsidering International Cannabis Policies: Vote on World Health Organization recommendations delayed

CBD in the USA

I’ve had the opportunity to attend several cannabis conferences and expos in the United States over the last year and many people who came by to talk to me would ask if they’re allowed to sell cannabidiol (CBD) products, both within and outside their home state. The move recently to approve GW Pharma’s Epidiolex®, in the U.S. is a significant one as it is an admission by the U.S. FDA that cannabis has medical value. On September 27, 2018, the Department of Justice and Drug Enforcement Administration (DEA) placed Epidiolex® on schedule V of the Controlled Substances Act, the least restrictive schedule of the CSA. This class is for medications with lower abuse potential. By classifying Epidiolex® as a schedule V drug, it will be made appropriately available to the public for medical use. All … [Read more...] about CBD in the USA