Why is GMP certification needed in the Cannabis Industry?
Just like any other product intended for human consumption, cannabis products must be safe, effective, and meet certain quality requirements, even more so where medical cannabis is concerned. To this end, regulatory bodies around the world have introduced, and are regularly updating cannabis-specific policies, upholding well-defined qualitative and quantitative standards for the production and distribution of marijuana and derived cannabis products. In the pharmaceutical and supplement industries, which share some essential characteristics with the Cannabis industry, these standards are collectively referred to as GxP. They comprise GLP (Good Laboratory Practice), GAP (Good Agricultural Practice), GDP (Good Distribution Practice) as well as many others, some of which are more prevalent. In this article, we focus on the all-important GMP (Good Manufacturing Practice). It is only a matter of time until GMP is universally adopted and implemented, and even before that, any manufacturer will benefit from adhering to its principles.
What is GMP in the Cannabis industry?
The basic assumption underlying GMP is that quality should be built into the product from start to finish. This covers a wide array of activities and permeates through the operation at every level. Its purpose is to assure that the manufactured products consistently meet the regulatory requirements for safety, identity, potency, quality and purity, thereby minimizing the risk for end users. GMP is an integral part of an organization’s Quality Management System (QMS). The successful implementation thereof will ensure the effectiveness, accuracy and consistency of the final product over time. Though GMP involves final product testing in certified quality-control laboratories, these do not suffice. GMP is meant to be implemented throughout the entire process, from sourcing raw materials to examining external supplier qualifications, until a final product with an approved shelf life is obtained.
GMP implementation in the cannabis industry is relevant for:
How to implement GMP in the Cannabis industry
Regulatory bodies like the FDA publish GMP guidelines covering all relevant industries. These guidelines stem from legislation, which is then translated into regulatory constraints. For example, the FDA, which receives its authority from the U.S Congress and is tasked with enforcing its health policies, realizes congressional law by formulating practical regulations for the industry to follow.
Due to the fact that cannabis is still considered illegal in most US countries. and at a national level, no dedicated GMP guidelines have been formulated as of yet. On the other hand, in many European countries, as well as in Australia and Canada, GMP guidelines for the cannabis industry have indeed been written and put to use.
For the time being, the global cannabis industry is generally unregulated, mainly due to legal and cultural issues which still persist, even in today’s society. But things are changing rapidly and nobody wants to be left behind. As a result, non-regulated territories where GMP is not clearly defined and enforced by the relevant government regulatory agencies suffer from an increased risk for unsafe and inefficient products reaching the market.
Based on our extensive experience in the medical, pharmaceutical, and global cannabis industries, and risk based approach, we created a unique GMP Quality Management System which can be implemented universally and will meet present and future GMP regulatory requirements in a relatively short time. Besides quality system establishment, Cannabis GxP focuses on staff training and skill building, and GMP implementation throughout the production chain. We guarantee our clients not only increased product quality but process control too. Successful GMP implementation will increase yields, minimize product waste and defects, and improve financial results.
About Cannabis GxP consultancy
Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.
Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.
We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.
Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.
Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the Pharmaceutical field, medical devices, Cosmetics and food supplements industry based in Israel.
Our cannabis consultancy services include:
If you need one or several of our services, we will be more than happy to assist.
Please do not hesitate to contact us for further information.