If you’re new to the world of medical cannabis, CBD or industrial hemp, you may not have come across the term Good Manufacturing Practice (also known as GMP) before. It is a complicated regulatory landscape that cultivators and manufacturers of medical cannabis must understand if they are to meet compliance standards.
We’re here to shine a light on what exactly this means, why it’s important and what the benefits of GMP are.
Table of Contents
What is Good Manufacturing Practice?
Good Manufacturing Practice (GMP) is essentially a set of guidelines that is recognised globally and ensures that products meet strict compliance standards. It is a certification that is a sure fast way of ensuring products are consistently produced and controlled to the highest standards of quality and safety.
Why is GMP important?
GMP is essential for ensuring cannabis-based products, including medicinal cannabis and CBD supplements, meet the regulatory requirements of the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food Standards Agency (FSA).
Good Manufacturing Practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:
- be of consistently high quality
- be appropriate to their intended use
- meet the requirements of the marketing authorisation (MA) or product specification
Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.
How do I meet GMP guidelines for medical cannabis?
Whether you are an established cannabis manufacturer or a new entrant to the market, following these 6 stages, UK cannabis manufacturers can ensure that their products meet the highest standards of quality and safety and are in compliance with all relevant regulations.
Get organized with a Quality Management System (QMS)
The first step in meeting GMP guidelines is to get organised with a QMS. This involves creating procedures for everything from quality control to personnel training. By having a solid QMS in place, you can ensure that your products are consistent and meet the highest standards of quality and safety.
Assess and Address Risks
To make sure your products are as safe as possible, it's important to assess and address any potential risks. This means identifying anything that could cause contamination or other issues and taking steps to mitigate those risks.
Keep Things Clean and Hygienic
One of the most important things you can do to ensure product safety is to maintain a clean and hygienic facility. This includes regular cleaning and disinfection of equipment and facilities, as well as ensuring that all personnel follow proper hygiene practices.
Testing is a key part of ensuring product quality and safety. By testing raw materials, in-process samples, and finished products, you can catch any issues before they become bigger problems. Make sure your testing program is comprehensive and covers both chemical and microbial testing.
Keep Detailed Records
Accurate and detailed record-keeping is essential for GMP compliance. By keeping good records of your manufacturing processes and testing results, you can identify any areas for improvement and ensure that you are meeting all relevant regulations.
Regularly Review and Improve
Finally, it's important to regularly review and improve your processes. This means conducting audits and identifying areas for improvement. By making ongoing improvements to your processes, you can ensure that your products are always of the highest quality and safety.
It is worth noting that companies wishing to manufacture cannabis-based medicinal products or active pharmaceutical ingredients require authorisation by both MHRA and the Home Office. A Home Office-issued Controlled Drugs (CD) licence is required for the cultivation, production, supply, and possession of cannabis. This requires an inspection by UK Home Office to ensure that appropriate procedures and facilities are in place to ensure the security of controlled substances. Meanwhile, the MHRA requires that companies can fully demonstrate their capability to adhere to manufacturing guidelines in order to grant an authorisation.
This unfortunately results in a ‘chicken and egg’ scenario for any new companies looking to enter the market, as completing all of the necessary processes required for the MHRA is not possible without permission to handle controlled substances, which in turn is not possible until one holds a Home Office license.
There currently isn’t a way to operate both authorisation processes independently because each regulatory authorisation process requires some aspects of the other. Only when both MHRA and the Home Office have granted appropriate authorisations, can medicines be supplied.
While discussions between the MHRA and the Home Office are currently taking place to find a more efficient solution to this challenge, there are currently a number of guidelines in place for companies that do not already hold the necessary authorisations from either of the government departments. You can check out our summary of these guidelines at this link.
We hope that this guide has provided you with insight into Good Manufacturing Practice and its benefits. To keep updated with more insights like this, make sure you’re following our social media channels or visit our website to learn more about our project.
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