Compliance is a word that is beginning to ring in the ears of the cannabis industry, but very few understand what compliance really is. There is a growing desire for GMP certification but no specific GMP certification for cannabis. What GMP can certify is the processes and procedures used in the manufacture of consumable materials. If you are curious how your practices would need to change to be considered GMP compliant, a gap assessment is the first place to start.
What is a Gap Assessment?
A gap assessment is an audit that is used to identify differences in current practices versus a given set of regulations. Gap assessments are often used in the GMP (Good Manufacturing Practices) certification process. Initial GMP certification is expensive, with costs easily reaching over ten thousand dollars. Before leaping into a certification, you may be more interested in finding out how close you are to compliance and what you need to change to become GMP compliant. You may also be interested in learning more about how GMP applies to you and the different types of certification available.
Standard Operating Procedures (SOPs) for CBD and Marijuana
SOPs are a major component of GMP that a lot of disinformation is rising up around in the US CBD and marijuana industries. Many companies think that they are much closer to GMP compliance because they have SOPs, but fail to realize that the SOPs are deficient, noncompliant, unvalidated, and are essentially invalid without the presence of a quality management system (QMS). Lots of cannabis consultants are popping up with excellent production knowledge and experience, but no context of quality systems and manufacturing.
While these weed masters for hire may be masters of industry, they have yet to master the skills you would encounter with a regulatory consultant. Regulatory consultants have had deep experience with production, manufacturing, and quality systems. They understand the business but leave the art up to you. You may have a great document with well-written instructions, but is it an SOP?
GMP SOPs for Cannabis Products
Good Manufacturing Practices (GMP) as defined by the Food and Drug Administration in 21 CFR part 110. These standards are the minimum sanitary and processing requirements for companies that produce consumable products like food, supplements, cosmetics, and pharmaceuticals. GMP is fairly broad and general and can be used to help guide the development of Standard Operating Procedures (SOPs) which are specific descriptions of processes.
Standard Operating Procedures (SOPs) can be defined as established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations. An SOP is a concise and specific step-by-step instruction. Establishments are encouraged to have SOPs for every task or activity in the facility. SOPs are useful in training employees and in establishing a consistent method for conducting daily operations.
Qualification, Validation, and Verification
Qualification of analytical instrumentation ensures accurate and precise measurement of analytical data. If the instrumentation is not qualified all other work based upon the use of that instrumentation is suspect. It is essential that validation and verification be performed using qualified instruments.
Validation is a process that substantiates that a procedure meets the requirements of the intended application. Without validation, there is no way to substantiate the suitability of a procedure. Validations are often an ongoing process that can take up to a year to gain sufficient data to assure the suitability of a procedure. After an initial validation, re-validations are required if any aspect of a process is changed, including the location and environment a procedure is performed in.
Verification is the observance of key indicators in a process. Verifications ensure that the procedure is being performed correctly as it was validated and that any unexpected occurrence in a procedure does not threaten the quality or safety of the final product.
What Does a Validated GMP Process Look Like?
Explaining GMP processes can be difficult and very technical. Here is an example of a GMP process and its qualification, validation, and verification that may help you understand how all of this compliance jargon works.
A laboratory produces skin grafts and must use sterile instruments to process the grafts. In order to sterilize their instruments, they must use an autoclave. What requirements must they meet to have a GMP-compliant procedure for sterilizing instruments in the autoclave?
- An SOP based on the manufacturer’s operation instructions as well as USP standards.
- A validation of the procedure using ampules of bacteria multiple times and in multiple locations to ensure the autoclave is capable of destroying spores and microorganisms; swabbing of sterilized instruments to ensure they are sterile.
- A qualification to ensure that the autoclave is functioning correctly and properly sensing pressure and temperature.
Based on these three points, the laboratory can begin using the autoclave.
Documentation: Every time the laboratory runs a cycle they will fill out a log (start time, cycle time and temperature, unloading time, operator initials, date, and contents of cycle). Weekly cleaning, maintenance, and verifications shall also be recorded.
Verification: The employee loading the autoclave will verify that it is mechanically sound by checking the gasket and water level. The instrument packs placed in the cycle will have an indicator on them that will change color only if the proper sterilization conditions are met. When the autoclave is unloaded the employee will make sure the indicator has changed color. Additionally, the laboratory will verify that the autoclave is working properly by running a microbial test ampule once per week. If at any point the autoclave fails to sterilize an ampule, or fails to sterilize a load, it will be placed out of service immediately until it can be repaired. After repair, the laboratory will re-validate the autoclave before it is placed back into use.
An autoclave sterilization process is much more straightforward than most process validations, and there is much more to GMP compliance than having SOPs. The process is just the beginning of compliance, but understanding what to validate and how can be very confusing!
Kush Lush Consulting can work with you to help you understand what you are getting into when you become a GMP facility. Whether you are in management or investment, everybody benefits from a better understanding of the regulatory framework.