Just like any business, a successful cannabis operation involves multiple processes that involve materials, equipment, and personnel. Adhering to Good Manufacturing Practices (GMPs), a globally recognized set of proactive best practices, ensures that your operation is maintained in a way to mitigate risks — risks of product failure, rework, recalls, and more.
Data collected throughout your processes provide management with the evidence that established processes and GMPs are being adhered to.
The data can also be trended and correlated to identify inefficiencies, serve as early warning signs of equipment aging, and more.
But first, it is critical to begin by understanding the 10 principles of GMP that apply no matter what type of cannabis operation you have.
Document these as part of your overall quality system and you will have a meaningful way to mitigate your operational risks and find opportunities for improvement — improving both your top and bottom lines!
So, what are they?
Standard Operating Procedures (SOPs) are stand-alone, step-by-step instructions which allow workers to consistently carry out routine operations, and documented training on SOPs confirms an employeeʼs comprehension of their job tasks.
Well written SOPs ensure controlled and consistent work and performance from employees of an organization, at all levels.
SOPs coordinate actions and communication across all shifts and between departments and different facilities.
Unfortunately, it is all too easy to write SOPs once, and let them collect dust in a binder – out of sight out of mind.
These procedures should be easy to follow and practical – a trusted resource that your front line employees can always turn to during the day.
You took the time to write up good procedures, but are they being followed?
Whether you call them Work Instructions, Standard Operating Procedures (SOPs) or something similar, these should be easily understandable for your team.
The best SOPs are written by the operators for the operators, and reviewed frequently to ensure changes in the process are reflected.
Following procedures prevents product mix-ups, minimizes errors and ensures the manufacture of high-quality consistent products.
You are now on your way to complying with GMP regulations!
Documentation of tasks and data should be done promptly and accurately.
Procedures should be implemented to ensure documentation is accurate, legible, original, and real-time.
Any raw data generated that may be used to make Quality decisions must be retained.
Without written evidence, there is no way to prove that procedures were followed correctly making investigations when something does go wrong difficult if not impossible.
Plus, this documentation can be trended and used to identify opportunities for improvement.
Proper design, construction, and location of a facility should be planned from the beginning.
Utilizing Quality by Design (QbD) principles minimizes product quality risk and maximizes manufacturing efficiency, capability, and output.
Have you considered the layout and product/process/personnel when designing your process? Even if you are already in operation, it is not too late.
Review your facility and equipment for risks — improperly designed operations create opportunities for microbial and particulate contamination as well as product cross contamination.
There must be controls in place for air and water quality, ventilation, lighting, temperature, and humidity to prevent any negative product impact.
Equipment should be qualified, key components calibrated, and properly maintained and repaired in a timely manner.
Having the most commonly replaced parts on hand and instituting a preventive maintenance program is a key component.
The majority of equipment failures can be attributed to a lack of preventive maintenance. Murphy’s Law always shuts your equipment down at the worst possible time.
The purpose of Validation is to ensure equipment and processes consistently perform as intended.
How else do you know that all of the equipment, materials and ingredients, and trained personnel have a reliable process that gives you the consistent product time in and time out?
A consistent performance is critical to maintaining safety and effectiveness of a product and enhances an organization’s reputation for quality and reliability.
In a nutshell, validation demonstrates control of critical operations.
Validation includes establishing ongoing monitoring and verification procedures which allows for troubleshooting and a process to address issues when they arise.
For example, your Preventative Maintenance (PM) and Calibration programs provide a critical mechanism for maintaining process control, production consistency, and efficiency.
A combination of proper education, training, and experience powers your staff to perform their assigned functions.
Training is a basic practice of GMP. Defined job descriptions, roles, and responsibilities ensure that your operation is staffed by the appropriately skilled staff.
Starting with an organizational chart enables senior management to ensure that the right skills are recruited for as your operation grows.
It is critical to establish appropriate training and competency requirements for all employees.
Accurate and organized records provide a way to track activities from the receipt of raw materials through final product release.
Records must be retained for receipt and inspection of components, containers, closures, and labels.
You are already properly documenting your work (Principle 3), having an organized system to maintain these records ensures you are able to review when necessary.
As the saying goes, “If it wasn’t documented, it didn’t happen!”
Contamination is the presence of any unwanted substance in a system or product.
Contamination presents itself in three (3) ways: Microbial, Particulate, and Product Cross Contamination.
It is all too easy to have mistakes lead to contamination — from a misplaced raw ingredient, a mislabeled or poorly labeled jar, to poor sanitation and hygiene practices resulting in microbial build up, failure to control contamination can be incredibly costly to an organization.
Be sure to have documented processes and procedures in place to be able to monitor and mitigate the risk of contamination in your operation.
Controlling for quality is much more than final process or product testing – known as Quality Control (QC).
You also need Quality Assurance (QA)! QA is the process of managing quality to minimize risk.
This includes ensuring that all products, from raw materials to final release, meet established standards and specifications, and are safe and effective.
Quality should be incorporated into every step of the product lifecycle.
The result? QC serves as the formality to verifying that all of your processes, and quality assurance steps are doing their job – providing consistent high quality products.
And when a final test result is questionable or does not meet specifications, you have the data to review and identify the root cause.
Internal audit programs allow organizations to conduct self assessments on the health of their Quality Management System (QMS) and overall operation.
Self assessments gauge compliance and identify gaps.
Establishing an internal audit program provides a proactive approach to identifying and resolving issues.
Documentation of internal audit activities provides objective evidence that an organization conducts its due diligence on compliance to standards and requirements, both internal and external.
The last principle – auditing for compliance is your answer to “Am I compliant?”.
Whether this be to your state laws, or the 10 principles of GMP, having an audit program is fundamental to knowing the health of your business.
The best audit programs involve staff with fresh eyes on an operational area.
Their lack of day-to-day familiarity with the process enables them to ask questions that operators take for granted and can be invaluable to identifying both non-compliance risks but also opportunities for improvement!
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