In an effort to ensure medical cannabis products are safe for consumers, many countries around the world are adopting Good Manufacturing Practice (GMP). GMP certification ensures creation of safe and effective medical cannabis products that are held to the highest manufacturing standards, much like traditional pharmaceutical products. As countries move to regulate medical cannabis products under the GMP umbrella, cannabis producers, manufacturers, and suppliers are having to understand and implement GMP in their businesses.
This article is the first part of a three-part series looking at what GMP is and its importance, the costs and benefits of GMP compliance, and the areas of the GMP process an equipment vendor can play a central role in.
With GMP becoming more significant in the cannabis industry, what is GMP?
GMP is a series of regulations that are enforceable by law, used to ensure products are consistently created in such a way as to meet rigorous quality standards. Typically, the agencies responsible for issuing GMP regulations are also responsible for enforcement. These regulations provide minimum requirements that a manufacturer must observe to ensure all products are safe, fit for the intended purpose, of high quality, and of consistent formulation or construction.
The regulations cover product categories including pharmaceuticals, food and beverages, dietary supplements and medical devices. GMP also covers all aspects of production from the raw materials, facilities, and equipment to the training and even personal hygiene of staff. This reinforces the primary goal of GMP: to prevent harm to end users of a product.
GMP regulations are not rigid instructions on how to manufacture products and structure processes. Such strict regulations would not only be impractical to translate across numerous industries, but it would also remove the motivation for manufacturers to innovate and adopt new technologies and methodologies. Instead, the requirements were established to be flexible, allowing manufacturers to determine the best way to implement scientifically sound design, processing systems, and testing procedures.
This flexibility allows adoption of the most up-to-date technology and methods, as well as letting companies decide the best way to implement the controls necessary to achieve the highest quality within their organizations. When manufacturing processes and quality systems are set up by a manufacturer, there may be many ways in which they can fulfill GMP requirements. The responsibility is on the manufacturer to determine the most effective and efficient quality process that meets both business and regulatory needs.
Is GMP always the same everywhere?
GMP guidelines and interpretations differ between both countries and regions, and even over time. Due to this consistent change, the most recent iterations are often referred to as Current Good Manufacturing Practice (cGMP). This system ensures that manufacturers use the most current systems and technology, as cutting-edge practices of 20 years ago may no longer be acceptable by current standards.
Why is GMP important?
First and foremost, GMP is for consumer safety. A consumer of medical cannabis products needs to trust the efficacy and quality of the products they are prescribed. Having checks and balances through GMP regulations gives manufacturers the ability to pick up on quality defects early and ensure unsafe products are not released to the public. There have been many documented cases where quality processes were not followed, and defective products were released. This highlights the importance of GMP regulations and the critical role they play in consumer safety.
For the businesses involved directly with medical cannabis, there are some distinct advantages of adopting GMP. Many authorities around the world, including the USA, Canada, Australia, Japan and the European Union (EU), require the application of GMP in the production of drugs, food, and cosmetics that will be sold in their respective markets. GMP certification will allow access to more markets. While GMP is not enforced in every country where cannabis cultivation is legal, it appears that GMP will become the norm for medical cannabis products and potentially for recreational products in the future. Thus, although GMP enforcement may not be required, lack of compliance could become a reason for restricted access to some markets and/or loss of sales.
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June 18, 2019 11AM Pacific / 2PM Eastern