Cannabis GMP Quality Certification Regulatory Guidelines

Cannabis GMP Quality Certification Regulatory Guidelines

The Medical Cannabis Quality Revolution

Though its health benefits have been known for hundreds of years, it’s only in the past few decades that the Cannabis plant has been subjected to methodical research. Over the past 20 years, many important cannabis studies and clinical trials were conducted and active materials such as CBD, THC and CBG have gained international credibility as pharmaceutical drug substances, with great potential to treat various diseases and other medical conditions. Aside from its clinically verified medicinal potential, cannabis differs substantially from most conventional pharmaceutical drugs in that the toxicity of it’s derived products is very low, and their side effects are minor in comparison.

Many good practices can, should and will be implemented in the cannabis industry. The motivation for adhering to a robust GxP framework is to ensure that patients around the world can benefit from safe, effective, pharma-grade cannabis products. Thus, a clear understanding of GMP and other good practices is nowadays essential for any stakeholder with a vested interest in the standardization of the cannabis industry, be it a grower, manufacturer, distributor, importer/exporter, health practitioner, researcher, or government official.

Cannabis Quality Regulation Guidelines Status

A brief review of regulation status in developed nations reveals that many have taken steps to standardize medical cannabis production and use. In Canada, the Cannabis agency is subordinate to the Canada health ministry, in Germany, to the Federal Institute for Drugs and Medical Devices, in Holland, to the Office of Medical Cannabis, in Australia, to the Therapeutic Goods Administration (TGA), and in Israel, to the Israeli ministry of health (IMOH).

In Israel and Germany, for example, growers and manufacturers are authorized to cultivate and supply cannabis based on their GAP and GMP certifications. Physicians are authorized to prescribe Cannabis products for a wide range of medical conditions and certified pharmacists are allowed to to sell them. Government agencies are also allowed to anonymously collect patient data and consumption habits for data analysis in order to facilitate the development and classification of cannabis strains and products according to their targeted medical conditions.

In order to take the Cannabis industry to the next step in terms of safety, efficacy, and quality, legislative systems should be established, monographs for Cannabinoids and final dosage forms should be developed and GMP guidelines should be written, published, followed and inspected by the relevant regulatory bodies.

About Cannabis GxP consultancy

Cannabis GXP is an Israel-based consultancy firm working within the cannabis industry.

We are currently engaged in revolutionizing the world of cannabis and hemp cultivation, production and regulation, and are reaching out to growers and manufacturers across the world who wants to join this amazing ride.

We are proud to stand at the forefront of the GMP standards and regulation fields in Israel and worldwide.

Our team is compelled to spread the message of the importance of cannabis 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.

We assist companies and growers with facility design, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP), training, and dealing with local and global regulation. Cannabis GXP strives to assist our clients with the development, manufacture and distribution of pharma-grade cannabis products, with a strong emphasis on safety, efficacy, and professionalism.

Cannabis GXP is a subsidiary company of Bio-Chem Ltd. (2007) – a consultancy company for Pharmaceutical, Medical Devices, Cosmetics, and Supplements, based in Israel (http://bio-chem.co.il/en/home/)

Some of our esteemed clients: Teva, Tikun Olam, J&J, Weizmann Institute of Science, BOL pharma, Seach, Nuuvera, Gamma-Cert, Cannabillis, Monsanto, Evogene, Collplant, Sigma-Aldrich, and many more.

Our Cannabis consultancy services include:

  • Investigational Cannabis product development and clinical trials
  • Cannabis growing & manufacturing facilities design
  • Cannabis Quality Assurance & Good practices (GxP)
  • Cannabis product manufacturing technology
  • Cannabis product regulation & FDA/EU submission
  • Novel Cannabis APIs and product delivery systems
2019-05-26T12:11:30+00:00

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