5 Tips to Avoid Common cGMP Violations

Departments - Upfront | Quick Tips

The top compliance issues at cannabis facilities and how to ensure your safety and quality practices meet guidelines.

July 12, 2021

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While state cannabis regulations generally require finished product testing, that alone will not guarantee product safety and quality. Good Manufacturing Practices (GMPs), or current Good Manufacturing Practices (cGMPs), are the guidelines and practices for processing products under safe and sanitary conditions.

After reviewing more than 100 cGMP cannabis facility audits, Cannabis Safety & Quality (CSQ) found that nearly half of the facilities were dinged for five common violations. Here’s how to avoid these non-conformances:

1. Document Environmental Monitoring.

Facilities should have a documented Environmental Monitoring Program (EMP) to prevent harmful cross-contamination from the environment and that meets cGMP audit requirements. A typical EMP includes sampling locations or zones, frequency of samples, testing methodology, acceptance criteria, and corrective actions. A good EMP program often encompasses a range of tests, such as Adenosine Triphosphate (ATP), which assesses surfaces for biological materials, indicator organisms to pathogens, spoilage organisms, and allergens. 

2. Challenge Security Plans Annually.

As part of cGMP requirements, facilities must have adequate security plans that mitigate intentional acts of adulteration. Companies are required to challenge security plans at least annually. Challenges can include sending a visitor into the facility to see how long it takes the person to be stopped by a frontline employee; leaving an unidentified package in a common area to see if employees notice, or having IT try to access employee computers to ensure they are secure. Walking the perimeter of the building to inspect external access door locks is not a direct challenge of a security plan. 

3. Establish a Preventive Maintenance Program.

A typical program includes a schedule outlining how the facility conducts preventive maintenance activities, including changing filters on HVAC equipment, applying lubricant to equipment, replacing worn rubber gaskets, etc. Most manufacturers provide an instruction booklet with the equipment’s maintenance schedule. Preventive maintenance programs also list employees responsible for these activities, what aspects are being maintained of the facility or equipment, and how often to replace items. 

4. Create Employee Training Programs.

Having a written employee training program covering cGMPs, basic Hazard Analysis Critical Control Point (HACCP, a food safety management program) principles, recalls, and security procedures is crucial to passing a cGMP audit. This may sound like an obvious requirement, but 43% of facilities audited by CSQ did not have a training program in place. A robust training program must include a qualified individual who teaches using understandable language, not jargon. Staff should then be tested to ensure they understood the material.

5. Track Suppliers and Approval Processes.

A typical supplier approval program includes selecting, evaluating, and approving new suppliers of raw materials such as flower, ingredients, or packaging materials. The approval process for temporary suppliers and methods for monitoring current suppliers should both be included in any facility’s supplier approval program. When evaluating suppliers, facilities will want to consider cost, availability, delivery time, customer service, and technical specifications, safety and quality. 

Lastly, facilities are required to keep an ongoing list of approved suppliers, including raw material specifications and other pertinent information such as a Certificate of Analysis (COA) and third-party audit results.

cGMP is a key tool for bringing safe products to market and avoiding costly recalls. A cannabis industry that supplies safe and quality products today may see fewer taxing demands from regulators tomorrow.

Tyler Williams is the founder and chief technical officer of Cannabis Safety & Quality.