There are numerous cannabis manufactures of edibles and concentrates that are bracing themselves for the State of California’s first licensing process that is slated to take effect January 1st, 2018. While the regulations, license fees, and formatting remain to be finalized, the majority of the requirements will stand. The most recent proposal has yet to be finalized but absent the final word from the regulators, it is easy to feel as if preparing your application is like trying to hit a moving target. There is certainly some truth in that, but there are some fundamental parts to the application process that are almost guaranteed not to change. By following these tips, and working with experts that understand Good Manufacturing Practices, you can put yourself at the front of the pack when application time comes around.
Tip 1: Obtain local authorization and support.
Even if your jurisdiction has not finalized their licensing process, the state has made it clear that local jurisdictions can provide a letter of authorization that will satisfy the state’s requirements to obtain a provisional license. In a future article, we will discuss the importance of gaining community support.
Tip 2: Have your business plan/pro forma prepared.
By over-preparing and having proof of the required surety bonds as well as sources of capital, the sprint to complete the application will be much less stressful, allowing you continued focus on your current operations.
Tip 3: Walk down your processes, document them, and build your Quality Management System.
How do you plan to document the solvents or oils used during the extraction? Have you verified they are of sufficient purity and unadulterated? Do you have your Calibration Plan written? What does your annual training plan look like? How about the documentation of critical control points during your manufacturing process?
Careful preparation is key.
These types of procedures can take months to prepare and vet, and it’s easy to get overwhelmed at first. Our experts with a background in manufacturing and compliance will assist you in preparing these documents so that you are prepared for a successful application submittal the first time. Don’t wait until the auditors show up, or even worse, a consumer product lawsuit is filed against you for alleging adulteration. Having the proper procedures and controls in place, and then following them will be your only form of protection if you end up in court.
At Orion GMP, we have been eating, sleeping, and breathing Good Manufacturing Practices and SOPs for longer than we’d like to admit. It’s common practice in practically every manufacturing industry in the world. But we acknowledge that it’s a learned process, and that it can seem overbearing and unnecessary without understanding the complexity of other highly regulated industries. Bridging our knowledge of Industry GMPs from both the process and auditing side with our expertise and passion for the cannabis industry allows us to strategically help you make sure you aren’t just complying with the regulations bestowed from above, but are utilizing them to safeguard product quality and also save money. It’s always harder to swim against the current, so if you are going to comply with the new regulations, why not make it profitable at the same time?
If you are interested in meeting California GMP Cannabis Guidelines, send us an email at email@example.com.
This content is written and supported by Orion GMP Solutions.