The cannabis industry has experienced disruptions across the supply chain from raw material suppliers to packaging and distribution, and this is not referring a lack of consumer packaged cannabis flowers on dispensary shelves. Companies have publicly made questionable claims in hopes of rapidly creating a brand name in a highly saturated market indifferent of product type. It seems every entrepreneur on the planet saw a golden opportunity to cash in on “weed” without any knowledge or understanding of the gravity of harm they might be causing. People (think patients) are buying products with label claims that the “brand name” can’t back up. As a consulting firm focused on advancing the quality of products to safeguard patients and those that may be harmed by lack of production controls, our team of experts draw quality control expertise from the most highly regulated industries that exist. Since our inception in 2015, our mission has been to educate the industry on how to utilize existing regulations and apply those to the manufacture of cannabis substances and cannabis products.
Products with label claims are a result of a well defined “biological system” that demonstrates a “cellular response” as well as data that when analyzed, correlates the dose of the cannabis product to the users perceived experience. Translated, there’s a lot of room for brands to make claims that fall squarely into the placebo effect – it’s false advertising. Brands looking to make claims would be better served by directly labeling the ingredients and making no claims until they sufficiently survey the market for user demand and preference. A product, by it’s nature, is representative of the process that created – considering the “art of the possible,” equipment manufacturers standardizing their equipment to meet customer GMP demands for cannabis substance and cannabis products.
Purchasers of equipment intended for cannabis substance and product manufacturing should be wary of any equipment manufacturer that claims they are “GMP Certified.” This is a misleading claim. Equipment by itself can not be GMP certified by it’s very definition. Equipment is included in the complex system of the manufacturing process, and does not stand alone as a “GMP Certified” system. According to the International Society of Pharmaceutical Engineers, “Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.“ ISPE further elaborates “GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.”
This means that GMP applies to all the elements of the process of creating a product, with the explicit goal of meeting a quality standard – i.e. specifications. Quality is a relative term by its nature until it is paired with a specification to be measured against. To that same end, Chapter 21 of Code of Federal Regulations Part 111 as well as Part 211 states that automated or mechanical equipment must be able to consistently meet specifications or perform the intended function to the expected performance. This is a vague statement but in application this can be applied easily if the premise is well understood. At the heart of stringent regulation lies the concept of “quality by design” as described in ASTM E2500 – 13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. Quality by design incorporates the appropriate planning and design phases to ensure that a product coming to market has been fully described in terms of characteristic attributes, means of manufacture and risks associated with the manufacture. The risks may include inherent variation of starting materials, process equipment or the nature of the substance or product being produced. The process and all it’s parts must be adequately managed such that the process consistently meets specifications that lead to products safe for human consumption.
All of these elements must be identified and documented to specify a product. That is the minimum requirement for a process to even touch on good manufacturing practice. Equipment manufacturers provide no justification of product outcomes based on equipment performance. Specifications are left to the unknowing recipient of the equipment to figure out once the check has cleared the bank. Generally, this is the point a third party must come in to aid the purchaser in completing what the equipment manufacturer should have done for the GMP price tag associated with the equipment. We highly recommend that purchasers of equipment have detailed user requirement specifications that describe the process, and verify whether the equipment in question will consistently produce conforming product. This must be agreed upon with the equipment manufacturer before purchase – not after.
More times than not we see single process pieces of equipment that are incapable of producing a useable cannabis substance or product. Vendor A must be cobbled together with vendor B and neither will guarantee the characteristics of the output product. To add insult to injury, many manufacturers wont include the most basic elements of GMP standards such as clean-ability or a sanitation program to ensure that the equipment will not adulterate products batch to batch.
At the end of the day, cannabis organizations and operators must have a detailed understanding of the product or substance they intend on creating so that they can approach equipment manufacturers with product specifications that they can hold them to. Without an expectation of outcome, it will be almost impossible to hit the bullseye in the time frame cannabis companies need to make sure their investment doesn’t sink. If you would like to know more about how to avoid the pitfalls of “GMP Certified” equipment contact us at firstname.lastname@example.org or visit our website at Orion GMP Solutions.