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GMP Overview

Topic

GMP or good manufacturing practices is a hot topic surrounding the manufacturing of cannabis products. Not only are consumers still unsure of cannabis use in itself, but they want risk assessment and security that these products are unharmful to health.

Manufacturing can be accomplished in many ways, but is best guided through the compliant framework called GMP. Let’s take a peak into what these practices mean to the cannabis industry and what compliance looks like no matter where you are.

What is GMP?

“GMP” or “good manufacturing practices” is a concept recognized and established in countries all over the world including, but not limited to, Australia, the United States, and Canada. Resources relating to each country can be found on the website of the International Society for Pharmaceutical Engineering.

A lot goes into manufacturing, especially in relation to the cannabis industry. Production involves solvents, or gases, pesticides, or other chemicals, distilling processes, and much more, in which is why GMP is a universal concept so that the products created for use on or in our bodies are safe and unharmful (even if the production process was potentially harmful). If you are familiar with relevant U.S. state regulations, then you are familiar with the discrepancies and specifications involved in tracking and disclosing use of additives, pesticides, etc.

In the US, GMP is overseen by the FDA (US Food and Drug Administration), and their purpose is to “[ensure] the quality of drug products.” They achieve this goal through monitoring and implementing regulations, particularly concerning manufacturing processes and packaging of drug products as well as the integrity of the ingredients and strength.

In the EU, GMP is overseen by the European Medicines Agency, in which their guidance and requirements are outlined. Since medical cannabis is legal in many EU jurisdictions, the regulations are more clearly drawn out, as in comparison to the US, which is legal only by state regulation.

The Australian Department of Health helps Australian licenses navigate GMP. Their guideline is called the “Therapeutic Goods (Manufacturing Principles) Determination” in which they apply their interpretation of GMP while aligning with universal interpretations. Similarly, this document references important subjects such as product quality reviews, risk management, and other safety practices.

There are 10 principles of GMP: define operating procedures and work instructions, follow your defined procedures, document your work, validate work through quality tests, facility and equipment should be well defined, maintain facility and equipment, demonstrate job competence, have good hygiene to protect drugs from contamination, design quality control, and perform regular audits.

Recommendations

GMP is a universal concept, but is also hefty, especially since each jurisdiction has their own interpretation for what this means through their regulations and guidelines. If you are looking to expand into a new location, our recommendation is to do your research. Being prepared is the best way to plan, build, and grow your business which can be done through personal research, contacting professionals, or networking with those in similar roadblocks. GMP, like many other compliance issues, is not a subject to be ignored.

Use the links in this small overview to begin your journey to expansion and let’s continue working together to spread the word about compliance issues and surpassing them.

 

 

 

 

Citations

Australian Government Department of Health. (2017, September 29). Questions & answers on the code of good

manufacturing practice for medicinal products. Retrieved September 27, 2019, from https://www.tga.gov.au/questions-answers-code-good-manufacturing-practice-medicinal-products.

Best video on 10 Principles of GMP | Good Manufacturing Practices. (2019, April 17). Retrieved October 8, 2019,

from https://www.bing.com/videos/search?q=gmp+standards+youtube&&view=detail&mid=11F20B9223A5E893261F11F20B9223A5E893261F&FORM=VRDGAR.

Center for Drug Evaluation and Research. (2018, March 30). Current Good Manufacturing Practice (CGMP)

Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

GMP Guidelines. (n.d.). Retrieved October 8, 2019, from

https://ispe.org/initiatives/regulatory-resources/gmp/regulatory-guidelines.

Guidance on good manufacturing practice and distribution practice: Questions answers. (2019, August 21).

Retrieved from https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers#eu-gmp-guide-part-i:-basic-requirements-for-medicinal-products:-chapter-1:-pharmaceutical-quality-system-(new-july-2018)-section.

Lahnakoski , K. (2019, April 18). APPLICATION OF GMP IN THE CANNABIS INDUSTRY. Retrieved from

https://www.cannabiscomplianceinc.com/application-of-gmp-in-the-cannabis-industry/

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