If you are a start-up in the cannabis extraction industry, you might have some big questions about implementing good manufacturing practices (cGMP). In the early stages, it’s a lot easier to start with a broad brush and capture the essentials than it is to try and achieve a perfect system.
Recently, Cannon Quality Group’s Andrew Cole, Director of Client Delivery, Audits was able to share his simple approach to cGMPs for Cannabis Extraction at the Cannabis Industry Journal’s Cannabis Extraction Virtual Conference. His method gives insight into how Cannon Quality Group approaches deconstructing overly complex quality systems to right-size your QMS processes.
You might not be familiar with cGMP or even understand how it can affect your cannabis operation. cGMP stands for current good manufacturing practice and can be summed up by following the five Ps:
Simply put, Andrew noted the goal here is to, “Keep whatever is outside from getting inside.” Anything in the environment –- such as plants, trees, pests, and insects — needs to stay in the environment. For example, a receiving bay should be protected by using air curtains or plastic drapes. Floor drains should be made of stainless steel with the added protection of an internal pest screen.
While it seems obvious that your facility needs to be clean, the details here matter. Floors, walls, ceilings, and light fixtures must be smooth and easily cleanable. Any area that could potentially harbor cross contamination of your product needs to be assessed.
People are critical to cGMP implementation. While employees must have sufficient training and knowledge to do jobs, this training has to be documented. Training records must be in place which show employees are competent, and that you’ve evaluated their competency.
Employees must wear clean clothing, personal protective equipment, and hair nets. They may not wear jewelry, false fingernails or eyelashes. This circles back to contamination; you must consider how your employees could contaminate your product.
Procedures, commonly called SOPs (standard operating procedures) are guidelines needed to perform a process. Andrew noted that the goal here is “to generate specific results repeatedly.” Employees should fully understand and follow procedures to prevent process errors.
Procedures may be two tiered: SOPs and work instructions (WI). SOPs give a general, high-level view of a process, while WI give a more detailed, specific how-to.
Procedures must be in place for all quality critical processes: receiving, processing, line clearance, calibration, etc. To develop effective procedures, Andrew recommended,
“Think of key questions when writing – who does what? What is the outcome? Did you answer what needs to happen clearly?”
To comply with cGMP, the primary materials (or raw ingredients) used to create a product need to be of the highest quality. Starting with good materials directly influences good products. All product must follow a single master formula without deviation. When deviations occur, they must be evaluated, investigated, and explained.
Clear specifications are required at every production phase.To ensure your product meets specification, you must implement secondary checks for critical weights, measures, and lab calculations. Raw materials and products must be received and placed in a holding area until they’ve been inspected. Product storage areas must be clearly identified and there should be designated areas which will prevent mix ups.
Any process that is followed in a cGMP facility must be documented. This includes processes such as document control. There must be a defined process for the creating, reviewing, approving, publishing, updating, and archiving documents and records.
Processes that can affect the quality of your product must be validated. Validation is simply making sure processes are working as intended, including cleaning. Validated processes ensure reproducibility and traceability.
cGMP ready – how?
Getting your cannabis extraction process cGMP ready can seem overwhelming. Andrews advocated for the ‘big to small’ approach. In the beginning, start big. Then as you progress, hone and refine your system over time.
Andrew’s parting advice:
- control production
- promote cleanliness
- prevent contamination
By following these fundamentals, you’ll be one step ahead in cGMP compliance for your cannabis extraction start-up.
If you’d like more information about implementing a quality management system, outsourcing quality assurance, quality system training, please contact us at firstname.lastname@example.org.
How do you deal with vendor qualification when suppliers have little GMP experience?
Include contractual requirements, and use the basic fundamentals of cGMP. If possible, make an on-site visit to the supplier t, ensure they can produce/reproduce a consistent quality product. Andrew does not recommend self assessments, because the answers are usually not 100% truthful.
Ensure quality is written into the contract with critical suppliers.
We’ve heard that ASTM (American Society for Testing and Materials) is working on developing standards for the cannabis production areas. Do you know if they are creating extraction industry standards?
Currently ASTM is developing standards for cannabis extraction. There are many different certification bodies that have developed their own version of GMP for cannabis cultivation & extraction. All are similar in nature, in that they are looking to identify and control risk through formal risk assessment, control of cross contamination, ensuring repeatability & consistency. Some small variations in standards are to be expected.
How long does it take to implement cGMP?
With enough resources and funding, a start up could implement a phase one, basic cGMP fundamentals in three to four months, while maintaining the other aspects of your organizational commitments. If these resources are available and the process exceeds nine months, you are probably overthinking it and overwriting it.