What is GMP / GPP standard for Cannabis?
GMP is defined as Good Manufacturing Practices. GPP is defined as Good Production Practices. In other words, it’s a collection of procedures, standards and practices to be implemented as part of company’s effective Quality Assurance system (QA). GMP principles cover a wide range of areas which have a direct or indirect impact on final product quality, efficacy and safety.
Originally GMP was created for the pharmaceutical industry, but was adopted also into the medical devices, food, cosmetics and supplements industries. The Good Practices principles are generally defined as GxP where the “X” in the middle stands for several areas which are relevant for final product quality and efficacy such as Laboratory (GLP), Clinical (GCP), Agriculture (GAP), Distribution (GDP), Storage (GSP), Security (GSeP), Engineering (GEP), Documentation (GDP) and others.
GMP in the pharmaceutical industry in the US is covered by guidelines such as 21 CFR parts 210 and 211, 21 CFR parts 110 and 111, 21 CFR part 112. In the EU, GMP is covered under guidelines such as ICH Q7. Due to the fact Cannabis is still illegal in many countries, there are no acceptable international standards or Current Good Manufacturing Practices for this industry. As a result, Cannabis GMP principles should be gathered from several different sources in order to be implemented successfully in the dynamic cannabis industry. Such as the American Herbal Products Association, and Americans for Safe Access standards that were partially adopted by the American Cannabis industry.
Unlike the US, many other countries such as Israel, Canada and Australia, have legislated that Cannabis growers and manufacturers should follow GMP standards to ensure that their Cannabis-based products are safe for human consumption and effective.
Why we need GMP in the cannabis industry?
In order to answer this question, we need to begin from the end. We would like our Cannabis products to be safe and effective. We would not like to harm our risk our lives using our cannabis products and not experience side effects, as a result of poor quality Cannabis product. We want it to have the required efficacy in order to achieve relief. Moreover, we would like it to be effective in treating medical conditions every time we take it.
Whether the cannabis products are being grown and produced for local distribution or for export outside the country, an appropriate level of quality assurance and control should be implemented, documented and inspected. The main purpose of the GMP in the Cannabis industry is to achieve a “pharma-grade” Cannabis product.
In order to achieve the desired quality and safety of Cannabis products we grow, manufacture, distribute and sell, we need to adopt procedures and quality standards and use best practices in our day to day cultivation, manufacturing and distribution activities and facilities in terms of cultivation, drying, storage, handling, cleaning, manufacturing, testing, packaging, distribution and documentation practices.
What may happen if not applying GMP in the Cannabis industry?
The failure to comply with GMP standards in the cultivation, manufacturing, processing, packaging or holding of Cannabis products, can cause such products to be adulterated and/or defective.
Although we cannot see worldwide GMP standards for the Cannabis industry, it is clear that in the near future, cannabis regulations will require GMP certification for local distribution or for imported Cannabis products. Even now we face lost sales opportunities due to the lack of GMP certification. More and more consumers and distributers and pharmacists selling Cannabis products and hemp CBD products, expect to see the GMP certification for their product.
The future Cannabis industry has to assure, using GMP and an effective Quality Management system, that regulatory bodies, patients and customers will trust Cannabis growers and Cannabis products manufacturers and distributors to provide them cannabis products which are free from heavy metals, contaminants and toxins, contain the declared active material content in a consistent manner, pure and high quality products. After all, most Cannabis and CBD products are being used as a medicine and therefore should be considered as “pharmaceutical-grade” products.
What is the difference between Cannabis GPP and GMP ?
GPP is Good Production Practices. GPP in comparison to GMP, is less holistic and extended. The GPP is focused on Cannabis products information existing on product label is “true” terms of Cannabinoids content although batch to batch consistency is not required yet. On the other hand, the GMP (Good Manufacturing Practices)covers many other quality aspects related to the Cannabis products such as control over raw materials, manufacturing process, in-process testing and controls, storage and distribution, validation and final product quality, including Cannabinoids content accuracy as well as batch to batch consistency.
About Cannabis GxP consultancy
Cannabis GXP is an Israeli-based Cannabis consultancy firm. Cannabis GXP is in the process of revolutionizing the world of cannabis and Hemp regulation and are reaching out to Cannabis growers and manufacturers who want to join this amazing ride with us. We are proud to be at the forefront of the GMP standards and regulation fields in Israel and all over the world. The team at CannabisGXP is compelled to spread the message of the importance of Cannabis regulation and standardization, as the world enters a new era. In this way, we hope that our clients will be positioned in the best way possible, with their best foot forward when it comes to anything and everything Cannabis related.
CannabisGXP is a leading consultancy firm, working within the Cannabis industry, overseeing the production of new cannabis products and extracts. 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/)
We also assist new companies and growers with new facility design, Quality Assurance, Good Practices (GAP/GMP/GDP), training as well as a strong emphasis on regulation in different countries. Cannabis GXP is focused on enabling our customers to develop, manufacture and distribute high quality pharma grade Cannabis-based products, with an emphasis on safety, efficacy, and professionalism
Among some of our bigger clients are Teva, Tikun Olam (the largest Medical Cannabis company in Israel.) J&J, Weizmann Institute of Science, BOL pharma, Seach, Nuuvera, Gamma-Cert, Cannabillis, Monsanto, Evogene, Collplant, Sigma-Aldrich and many others.
OUR CANNABIS CONSULTANCY SERVICES INCLUDE:
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