Detroit, MI, February 19, 2019 --(PR.com
)-- As the evolution of the medicinal marijuana space continues to evolve globally at a rapid pace, guidance from state regulatory bodies in the United States consistently demonstrate an opportunity to clearly define the gold standard regulations of medicinal marijuana cultivation and processing. Taking it even a step further, there is a great deal of variability in the current era on the foundation of safe cannabis dispensing – starting with toxicology - creating a significant concern to overall patient safety.
Pharmaceutical Innovation Enterprises has committed to creating and establishing the gold standard of cannabis toxicological data points and guidelines, under the direction of its Chief Executive Officer, Dr. Ahzam Afzal. With a strong background in Pharmacology, Toxicology, Pharmaceutical Manufacturing and Cannabis Strain Mapping, Dr. Afzal has pooled a team of toxicologists, pharmacists, and scientists to orchestrate the development of methodological and technical guidelines to ensure the highest level of purity in all stages of the manufacturing process, driven to deliver the best patient safety outcome data.
Pharmaceutical Innovation Enterprises has meticulously developed a tri-phasic approach to cannabis testing, with a high level of specificity in each step of the process. His novel approach, focused heavily on the science behind solvents, pesticides, and heavy metals was developed with one purpose in mind – patient safety. “There needs to be a high-level of responsibility in each step of the process from cultivation to processing to toxicology testing. We have the opportunity to set the gold standard on what these regulations look like. From a pharmaceutical manufacturing perspective, Title 21 of the Federal Code of Regulations, Part 211 identifies the cGMP expectations for all drug manufacturers. The same set of expectations is what I will expect from my team, this is no different – we are talking about medicine,” Dr. Afzal said. The first element of his tri-phasic approach to cannabis testing was related to solvents. “We will first have to eliminate the use of highly dangerous solvents, like benzene, as there is a direct impact to patient safety, and it is simply not needed in the manufacturing process. We really should limit solvent use to Class 3 solvents. If we couple that with action limits that are in-line with USP and OSHA regulations, we now have a mechanism to standardize and deliver on this approach with the highest level of patient safety,” Dr. Afzal explained. His stance on pesticide testing was also intuitive as he believes there needs to be a classification in place to regulate pesticides based on their characteristics and associated allowable limits. “There is a great deal of variability in pesticide levels in both raw plant and post-extraction, and we are building action limit protocols based on data published by the World Health Organization (WHO) to create a fundamentally sound testing solution,” Dr. Afzal said.
Pharmaceutical Innovation Enterprises is committed to leading the way in pharmaceutical research, in a manner that maintains utmost compliance driven to positively influence patient outcomes. As the industry continues to demand market differentiation, there is a need for intricate research data as it pertains to patient outcomes.