Like any business, a successful cannabis business involves multiple processes involving materials, equipment and people. Adhere to Good Manufacturing Practices (GMP), a globally recognized set of proactive best practices that ensure your operations are maintained in a way that reduces risk – product failure, rework, recalls and more.

Data collected throughout the process provides management with evidence of compliance with established processes and GMPs.

Data can also be trended and correlated to identify inefficiencies, serve as early warning signs of equipment aging, and more.

But first, it’s important to first understand the 10 GMP principles that apply to any type of cannabis Operation you have.

Document these as part of your overall quality system and you’ll have a meaningful way to reduce your operational risk and find opportunities for improvement – increasing your revenue and profits!

So what are they?

Principle 1 – Writing Programs

Standard Operating Procedures (SOPs) are self-contained step-by-step instructions that enable workers to consistently perform day-to-day operations, and documented SOP training confirms employees’ understanding of their job tasks.

A well-written SOP ensures that the work and performance of employees at all levels of the organization is controlled and consistent.

SOPs coordinate all shifts and actions and communications between departments and different facilities.

Unfortunately, it’s all too easy to write SOPs once and then have them collect dust in binders — see and forget.

These procedures should be easy to follow and practical – your frontline trusted resource employee It is always possible to turn during the day.

Principle 2 – Follow written procedures

You took the time to write good programs, but are they followed?

Whether you call them Instructions of Work, Standard Operating Procedures (SOPs), or something similar, it should be easy for your team to understand.

Optimal SOPs are written by operators for operators and are frequently reviewed to ensure changes in the process are reflected.

Following procedures prevents product mix-ups, minimizes errors and ensures a high-quality, consistent product.

You are now complying with GMP regulations!

Principle 3 – Properly document work

Tasks and data should be recorded in a timely and accurate manner.

Procedures should be implemented to ensure documentation is accurate, legible, original and current.

Any raw data generated that can be used to make quality decisions must be preserved.

Without written evidence, it is impossible to prove that procedures were followed correctly, and it is difficult, if not impossible, to investigate when something goes wrong.

Additionally, this document can be trended and used to identify opportunities for improvement.

Principle 4 – Facilities and Equipment

appropriate designThe construction and site selection of the facility should be planned from the outset.

Utilize Quality by Design (QbD) principles to minimize product quality risk and maximize manufacturing efficiency, capacity, and yield.

Did you design the process with layout and product/process/people in mind? Even if you’re already operating, it’s not too late.

Check your facilities and equipment for risks – poorly designed operations create opportunities for microbial and particulate contamination and product cross-contamination.

Air and water quality, ventilation, lighting, temperature and humidity must be controlled to prevent any negative effects on the product.

Equipment should be qualified, key components calibrated, and properly maintained and repaired in a timely manner.

Having the most frequently replaced parts and having a preventive maintenance schedule are key components.

Most equipment failures can be attributed to a lack of preventive maintenance. Murphy’s Law always shuts down your device at the worst possible time.

Principle 5 – Validation Process

The purpose of validation is to ensure that equipment and processes consistently perform as expected.

How do you know that all the equipment, materials and ingredients, and trained personnel have a reliable process that will give you consistent product in and out times?

Consistent performance is critical to maintaining the safety and effectiveness of products and enhancing an organization’s reputation for quality and reliability.

In short, validation demonstrates control over key operations.

Validation includes the process of establishing ongoing monitoring and verification procedures to troubleshoot and resolve issues as they arise.

For example, your preventative maintenance (PM) and calibration programs provide key mechanisms for maintaining process control, production consistency, and efficiency.

Principle 6 – Demonstrate work ability

A combination of appropriate education, training and experience enables your employees to perform their assigned functions.

Training is the basic practice of GMP. Clear job descriptions, roles and responsibilities ensure your operations are staffed with the right skills.

Starting with an org chart, senior managers can ensure that the right skills are recruited as the business grows.

It is critical to develop appropriate training and competency requirements for all employees.

Principle 7 – Good Record Keeping

Accurate and organized records provide a way to track activities from raw material receipt to final product release.

Records must be maintained for receipt and inspection of components, containers, closures and labels.

You have properly documented your work (principle 3), and having an organized system to maintain these records ensures that you can review them when necessary.

As the saying goes, “If it wasn’t documented, it wouldn’t have happened!”

Principle 8 – Control pollution

Contamination is the presence of any unwanted substances in a system or product.

Contamination manifests in three (3) ways: microorganism, Particulate matter and product cross-contamination.

Mistakes can easily lead to contamination—from misplaced ingredients, mislabeled or improperly labeled jars, to poor hygiene and hygiene practices that lead to the buildup of microbes, failure to control contamination can be costly to organizations.

Make sure there are written processes and procedures in place to be able to monitor and reduce the risk of contamination in your operation.

Principle 9 – Quality Control

Quality control is more than just final process or product testing – called Quality Control (QC).

You also need Quality Assurance (QA)! Quality assurance 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 life cycle.

result? QC serves as a form of verification that all of your processes and quality assurance steps are working – delivering a consistently high quality product.

When final test results are questionable or out of specification, you can review the data and determine the root cause.

Principle 10 – Compliance Audit

Internal audit programs allow organizations to self-assess the health of their quality management system (QMS) and overall operations.

Self-assessment measures compliance and identifies gaps.

Establishing an internal audit program provides a proactive approach to problem identification and resolution.

Documentation of internal audit activities provides objective evidence that an organization has performed due diligence in compliance with internal and external standards and requirements.

The last principle – a compliance audit is your answer to “Am I compliant?”

Whether it’s for your state’s laws or the 10 principles of GMP, developing an audit plan is critical to understanding the health of your business.

The best audit programs involve employees who have a fresh perspective on the business area.

Their lack of day-to-day familiarity with the process allows them to ask questions that operators take for granted and is invaluable both for identifying non-compliance risks and opportunities for improvement!