top of page

A Guide to GMPs in Cannabis and Hemp for 2024

GMPs in Cannabis - Featured Image

While the cannabis industry has been on an upward trend since the Farm Bill in 2018, safety and quality are paramount when it comes to creating safe, reliable products.

But, with a long list of FDA guidelines and regulations, it can be challenging to navigate the complex regulations and practices in this industry, especially for those new to the field.

That’s where this article comes in. We’ll guide you through the Good Manufacturing Practices (GMPs) for cannabis that are necessary for businesses to follow to be considered legal and to meet regulatory standards set forth by the US Government and the FDA.

Key Article Highlights

  • Good Manufacturing Practices (GMPs) are critical in the cannabis industry to ensure products are consistently produced and controlled according to quality standards, helping to minimize risks such as contamination and errors.

  • Key components of GMP include quality management, proper design and maintenance of facilities and equipment, and ensuring personnel are adequately trained, all of which contribute to the overall safety and efficacy of cannabis products.

  • Compliance with GMP standards not only ensures high-quality and safe cannabis products but also helps businesses navigate complex regulatory environments, enhancing consumer trust and business credibility in the competitive market

What are Good Manufacturing Practices (GMPs) in Cannabis and Hemp?

Good Manufacturing Practices (GMPs) are a set of guidelines that provide a system of processes, procedures, and documentation to ensure a product has the identity, strength, composition, quality, and purity that appear on its label. GMPs are required by the FDA for the production of drugs, foods, dietary supplements, and cosmetics. 

The purpose of following GMP is to minimize the risks involved in any cannabis production that cannot be eliminated through testing the final product. This includes contamination risks, mix-ups, deviations, failures, and errors. GMP guidelines detail the minimum requirements that a cannabis manufacturer must meet to ensure that their products are high quality, safe, and effective.

The key components of GMP include:

  • Quality Management: Establishing a strong quality management system is one of the critical parts of GMPs in cannabis. Key elements include a quality policy, quality objectives, quality manual, organizational structure and responsibilities, resource management, and regular management reviews of process performance and product quality.

  • Facilities and Equipment: Manufacturing facilities must be suitable for their intended use and be adequately designed to facilitate proper operations, cleaning, and maintenance. Major equipment must be maintained and cleaned regularly according to written procedures.

  • Personnel: Employees must have the necessary education, training, and experience to perform their assigned duties. They must also follow good sanitation and health habits.

  • Production and Process Controls: All production processes must be clearly defined, monitored, and controlled. Any changes or updates to the processes must be evaluated and documented.

What are Good Manufacturing Practices (GMPs) in Cannabis and Hemp?

Good Manufacturing Practices (GMPs) are quality control guidelines that ensure cannabis and hemp products are consistently produced and controlled according to strict quality standards. GMPs cover all aspects of production, from raw materials and facility operations to employee training and product testing, to guarantee safe and effective products.

GMPs provide a framework for manufacturers to establish and maintain a quality system that ensures product safety, purity, and potency. By implementing GMPs, you:

  • Minimize contamination risks

  • Ensure consistent product quality

  • Comply with regulations

  • Protect consumer health

  • Enhance operational efficiency

  • Improve traceability and recall management

  • Boost customer confidence in your brand

GMPs apply to various aspects of cannabis and hemp manufacturing, including:

  1. Facility design and maintenance

  2. Equipment selection and calibration

  3. Raw material sourcing and testing

  4. Production processes and controls

  5. Packaging and labeling

  6. Storage and distribution

  7. Personnel training and hygiene

  8. Record-keeping and documentation

Here are the core features of GMP for cannabis in the United States.

1. Develop Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) are the backbone of your GMP compliance efforts. They provide a clear, step-by-step roadmap for every process in your cannabis or hemp manufacturing facility, from receiving raw materials to shipping finished products.

SOPs ensure that all employees perform tasks consistently and according to best practices. This consistency is key to maintaining product quality, safety, and compliance with regulations. Well-written SOPs also serve as valuable training tools for new employees and help minimize errors and deviations.

Elements of Effective SOPs

  • Clear and Concise Language: Write SOPs in simple, easy-to-understand language, avoiding jargon and technical terms when possible. Use active voice and present tense.

  • Step-by-step Instructions: Break down each process into detailed, sequential steps that are easy to follow. Include specific measurements, temperatures, and other critical parameters.

  • Visual Aids: Incorporate photos, diagrams, and flowcharts to clarify complex processes and make the SOPs more user-friendly.

  • Roles and Responsibilities: Clearly define who is responsible for each task and include any necessary qualifications or training requirements.

  • References: Include references to relevant regulations, industry standards, and other supporting documents.

Maintaining Your SOPs

SOPs are living documents that should be regularly reviewed and updated to reflect changes in processes, regulations, and best practices. Establish a schedule for reviewing and revising your SOPs, and ensure that all employees are trained on any updates.

By investing time and resources into developing comprehensive, user-friendly SOPs, you lay the foundation for a robust GMP compliance program that will help you consistently produce high-quality, safe, and effective cannabis and hemp products.

2. Train Your Employees

Employee training is a fundamental aspect of implementing GMPs in your cannabis or hemp manufacturing facility. Every team member, from production line workers to quality control specialists, plays a crucial role in ensuring product safety and consistency.

Develop a Comprehensive Training Program

  • Tailor Training to Specific Roles: Create training modules that address the specific GMP requirements and responsibilities for each position within your organization.

  • Make Training Engaging and Interactive: No one likes to sit in a meeting room and look at slides for 6 hours. Use a mix of classroom instruction, hands-on demonstrations, and e-learning modules to keep employees engaged and reinforce key concepts.

  • Incorporate Real-world Examples: Use case studies and scenarios from your own facility to illustrate the importance of GMP compliance and the consequences of non-compliance.

Assess and Refresh Training Regularly

Employee training is not a single-instance event. It’s an ongoing process that has to be refreshed every year or after predetermined intervals to ensure that employees are still on top of their training and are up-to-date with new industry standards.

Schedule refresher courses and updates to inform employees of changes in regulations, industry best practices, and company policies.

It is also important to foster a culture of learning and encourage employees to suggest improvements to processes and procedures that enhance GMP compliance.

3. Establish a Quality Management System (QMS)

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. In the context of GMPs for cannabis and hemp, a QMS:

  • Ensures Consistency: A well-designed QMS helps you maintain consistent product quality by standardizing processes and procedures across your organization.

  • Facilitates Continuous Improvement: By regularly monitoring and analyzing key performance indicators (KPIs), you can identify areas for improvement and implement corrective actions to enhance your GMP compliance and overall operational efficiency.

  • Streamlines Documentation: A QMS provides a centralized platform for managing all GMP-related documentation, including SOPs, batch records, and quality control test results. This streamlined approach simplifies regulatory compliance and facilitates rapid problem-solving.

Elements of an Effective QMS

There are a few elements that need to be a part of your QMS to improve its overall efficiency and to help it improve your overall process.

1. Quality Policy: Develop a clear, concise quality policy that outlines your organization's commitment to GMP compliance and continuous improvement. Communicate this policy to all employees and stakeholders.

2. Quality Manual: Create a comprehensive quality manual that describes your QMS in detail, including your quality policy, organizational structure, and key processes and procedures.

3. Document Control: Establish a document control system to ensure that all GMP-related documents are properly created, reviewed, approved, and version-controlled. This system should also ensure that only the most current versions of documents are in use.

4. Training and Competency: Implement a comprehensive training program to ensure all employees have the necessary skills and knowledge to perform their GMP-related duties effectively. Regularly assess employee competency and provide ongoing training as needed.

5. Internal Audits: Conduct regular internal audits to assess the effectiveness of your QMS and identify areas for improvement. Use the findings from these audits to implement corrective and preventive actions (CAPAs) and drive continuous improvement.

6. Management Review: Schedule periodic management reviews to evaluate the performance of your QMS and make strategic decisions to improve GMP compliance and overall operational efficiency.

By establishing a well-designed QMS, you create a solid foundation for ensuring consistent GMP compliance and producing high-quality, safe cannabis and hemp products that meet the market's development standards.

GMPs in Cannabis - Supporting Image 1

4. Conduct Regular Audits and Inspections

Regular audits and inspections help you proactively identify and address any GMP non-conformances, ensuring ongoing compliance and continuous improvement.

In order to run an efficient auditing process, it’s important to establish an internal audit schedule covering all aspects of your GMP program, from facility and equipment maintenance to production processes and quality control testing.

To ensure that your audits result in actionable outcomes, maintain detailed records of findings, including any non-conformances and the corrective actions taken to address them. Use this information to track trends and drive continuous improvement.

Third-party Inspections

Apart from internal audits, it can also be helpful to partner with reputable third-party inspection firms specializing in GMP compliance for the cannabis and hemp industry. These experts bring a fresh perspective and can help identify areas for improvement that may be overlooked by internal teams.

Third-party inspections can be a great way to validate your internal audit program and prioritize areas for improvement. Incorporate these insights into your continuous improvement initiatives to strengthen GMP compliance.

Corrective and Preventive Actions (CAPAs)

Once audits highlight the gaps in your system, it’s important to have a well-defined procedure to mitigate the errors.

  • Investigate Root Causes: When non-conformances are identified during audits or inspections, conduct thorough investigations to determine the root causes. This may involve interviewing employees, reviewing documentation, and analyzing process data.

  • Develop Targeted Solutions: Based on the root cause analysis, develop targeted corrective actions to address the immediate non-conformance and preventive actions to mitigate the risk of recurrence.

  • Monitor Effectiveness: Establish a system for monitoring the effectiveness of your CAPAs over time. This may involve conducting follow-up audits, tracking relevant metrics, and soliciting feedback from employees and stakeholders.

5. Ensure Facility and Equipment Compliance

Your facility's design and layout directly impact your ability to maintain GMP compliance. A well-designed facility promotes a logical flow of materials and personnel, minimizes the risk of contamination, and facilitates effective cleaning and maintenance.

Key Considerations for Facility Design

  • Segregation of Areas: Clearly define and separate areas for receiving, storage, production, packaging, and quality control to prevent cross-contamination.

  • Material Flow: Design your facility to ensure a unidirectional flow of materials, from raw ingredients to finished products, to minimize the risk of mix-ups and contamination.

  • Environmental Controls: Implement appropriate temperature, humidity, and air filtration controls to maintain product quality and stability.

  • Cleanable Surfaces: Use smooth, non-porous, and easily cleanable materials for floors, walls, and ceilings to facilitate effective sanitation.

  • Adequate Lighting: Provide sufficient lighting in all areas to enable proper cleaning, maintenance, and operations.

Equipment Selection and Maintenance

The equipment you use in your cannabis or hemp manufacturing facility must be suitable for its intended use, easy to clean and maintain, and capable of consistently producing high-quality products.

Select equipment made from materials that are compatible with your products and cleaning agents to prevent contamination and corrosion. Similarly, it’s important that the equipment and all of its surfaces are easily accessible and regularly cleaned.

Apart from that, all critical measuring and monitoring equipment must be regularly calibrated to ensure accurate and reliable results.

Sanitation and Hygiene

Other than facility cleanliness, it’s important to establish protocols for sanitation on other levels as well.

  • Cleaning Procedures: Develop and implement detailed cleaning procedures for all areas of your facility, including production areas, storage areas, and common spaces.

  • Validated Cleaning Methods: Use validated cleaning methods and agents to remove contaminants and residues effectively.

  • Personnel Hygiene: Establish and enforce strict personnel hygiene policies, including requirements for protective clothing, handwashing, and health monitoring.

  • Environmental Monitoring: Conduct regular environmental monitoring to verify the effectiveness of your cleaning and sanitation programs and identify any potential sources of contamination.

6. Implement Effective Pest Control Measures

An effective pest management program is a key component of GMP compliance in cannabis and hemp manufacturing facilities. Pests such as insects, rodents, and birds can introduce contaminants, compromise product quality, and pose significant health risks to consumers.

Develop a Comprehensive Pest Management Plan

Your pest management plan should be tailored to your facility's specific needs and include:

  • Preventive Measures: Seal potential entry points, maintain a clean and tidy facility, and implement strict sanitation protocols to discourage pest activity.

  • Monitoring Procedures: Regularly inspect your facility for signs of pest activity using visual inspections, traps, and other monitoring devices.

  • Control Strategies: Establish clear guidelines for the use of pesticides, traps, and other control measures, ensuring compliance with all relevant regulations.

Implement Integrated Pest Management (IPM)

IPM is a proactive, science-based approach to pest control that minimizes reliance on chemical pesticides and prioritizes prevention and non-chemical interventions.

Key elements of an IPM program include:

1. Identification: Accurately identify pests and understand their biology and behavior to inform control strategies.

2. Prevention: Implement facility design and maintenance practices that discourage pest activity, such as sealing cracks and crevices, maintaining proper sanitation, and controlling moisture levels.

3. Monitoring: Regularly inspect your facility for signs of pest activity, using visual inspections, traps, and other monitoring devices to detect problems early.

4. Intervention: When pest activity is detected, use targeted, low-risk control measures such as traps, barriers, and non-chemical treatments whenever possible. Only use chemical pesticides as a last resort, and ensure proper application and documentation.

Partner with a Licensed Pest Control Operator

Consider partnering with a licensed pest control operator specializing in GMP-compliant pest management for cannabis and hemp facilities. These experts can provide valuable guidance on developing and implementing an effective pest management plan, as well as conducting regular inspections and treatments.

7. Establish a Recall Plan

In 2024, as the cannabis and hemp industry continues to evolve, having a recall plan in place is more important than ever. A recall plan outlines the steps you will take to quickly and efficiently remove any non-compliant or potentially harmful products from the market, minimizing risks to consumers and protecting your brand reputation.

Elements of an Effective Recall Plan

  • Recall Team: Designate a cross-functional recall team, including representatives from quality assurance, regulatory affairs, legal, and communications departments. Clearly define roles and responsibilities for each team member.

  • Traceability: Implement a comprehensive traceability system that allows you to quickly identify and locate affected products, from raw materials to finished goods. This may involve assigning unique batch numbers, using barcodes or RFID tags, and maintaining accurate production records.

  • Communication Protocols: Establish clear communication protocols for notifying regulatory authorities, customers, and the public about a recall. This should include templates for press releases, customer notifications, and regulatory reports.

  • Retrieval and Disposal: Develop procedures for retrieving affected products from the market and disposing of them safely and securely. This may involve coordinating with distributors, retailers, and logistics providers to ensure a smooth and efficient recall process.

GMPs in Cannabis - Supporting Image 2

8. Partner with GMP-Compliant Suppliers

Adhering to manufacturing and distribution GMPs can be an expensive process, especially for companies that are relatively new in the cannabis industry.

Partnering with GMP-compliant suppliers is a reliable way of getting top quality products without having to deal with the financial aspect of managing your own GMP facility.

When selecting suppliers, look for those who:

1. Hold GMP Certifications: Suppliers who have achieved GMP certification from reputable third-party auditors demonstrate their commitment to quality and safety. These certifications assure that their facilities, processes, and products meet stringent GMP standards.

2. Provide Comprehensive Documentation: GMP-compliant suppliers should readily provide you with detailed documentation, including certificates of analysis (COAs), specifications, and safety data sheets (SDSs). This documentation helps you verify the quality and consistency of the materials you receive and facilitates your GMP record-keeping and traceability efforts.

3. Have a Proven Track Record: Seek out suppliers with a history of consistently delivering high-quality materials and exceptional customer service. Ask for references from other cannabis or hemp manufacturers and conduct thorough due diligence before entering into long-term supply agreements.

4. Offer Transparency and Collaboration: The best suppliers are those who view you as a partner, not just a customer. They should be transparent about their own GMP programs and welcome your questions and feedback. Look for suppliers who are willing to collaborate with you on quality improvement initiatives and are proactive in communicating any potential issues or changes that may impact your business.

Benefits of GMP-Compliant Suppliers

Partnering with GMP-compliant suppliers offers numerous benefits for your cannabis or hemp manufacturing business, including:

  • Reduced Risk: By sourcing materials from suppliers who adhere to GMP standards, you minimize the risk of introducing contaminants or other quality issues into your production process. This, in turn, reduces your risk of costly recalls, regulatory penalties, and reputational damage.

  • Increased Efficiency: GMP-compliant suppliers are more likely to consistently deliver materials that meet your specifications, reducing the need for rework or rejection. This can help streamline your production process and improve overall efficiency.

  • Enhanced Traceability: Suppliers who maintain detailed documentation and traceability records make tracking the origin and movement of your raw materials throughout your supply chain easier. This enhanced traceability is crucial for demonstrating GMP compliance and quickly identifying and addressing any potential issues.

  • Competitive Advantage: In 2024, as the cannabis and hemp industry becomes increasingly competitive, partnering with GMP-compliant suppliers can give you a significant advantage in the marketplace. The suppliers can handle quality control, giving you the bandwidth to focus on marketing and other aspects of your business.

Benefits of Adhering to GMPs in Cannabis and Hemp Manufacturing

Ensuring adherence to Good Manufacturing Practices (GMPs) brings multiple advantages to cannabis and hemp manufacturers. These standards act as a foundation for producing reliable and safe products, fostering a positive public perception and ensuring regulatory compliance.

Key benefits include:

Reduced Risk of Contamination and Better Quality Produce

Following GMP guidelines minimizes the possibility of contamination or errors during the production process, significantly reducing the likelihood of costly recalls.

Apart from that, GMPs ensure that products are consistently produced to a set quality standard, which helps build a loyal customer base.

Greater Access to Funding and Investment Opportunities

Compliance with GMP standards can make cannabis and hemp businesses more attractive to investors and financial institutions. 

This can open endless opportunities for your enterprise to expand into other parts of the cannabis industry and open distribution routes into other states and cities in the United States.

Reduced Legal Liabilities

Adherence to GMPs ensures that manufacturers meet regulatory requirements, thereby avoiding legal issues and penalties.

By working with suppliers that keep FDA regulations in mind, you reduce your chances of being flagged by the organization, which can be disastrous for a business in the cannabis industry.

Final Thoughts

Adopting GMPs is a strategic move for cannabis and hemp manufacturers aiming to distinguish themselves in a competitive market. These practices ensure product safety and quality and solidify a company's reputation in the industry. Manufacturers who prioritize GMP compliance are well-positioned to lead in product innovation and customer satisfaction.

If you’re hesitant to enter the cannabis market because of complex GMP standards, you should definitely consider reputable suppliers like Arvida Labs.

Arvida Labs is one of the biggest names in cannabis advocacy in the United States and has made considerable advancements to create safe and reliable cannabis products. 

If you’re looking for a cannabis supplier to provide high-quality, safe, potent cannabis products manufactured in a GMP-certified facility, Arvida Labs is a top contender in the market.

How Arvida Labs Can Support Your Business

Arvida Labs understands the challenges and opportunities of maintaining GMP compliance in the cannabis and hemp industry. 

We offer a range of services tailored to the needs of the cannabinoid industry:

  • Bulk Liter Processing: Leveraging advanced manufacturing techniques and expert insights to produce cannabinoids at competitive prices.

  • Custom Formulations: Collaborating with clients to develop unique hemp-derived products, incorporating current market trends and target audience needs.

  • Filling: Utilizing precise filling capabilities to ensure consistent product quality, suitable for various device types.

  • Blending: Providing pre-mixed liters for streamlined manufacturing of finished goods, minimizing potential errors.

  • Terpene Profiling: Offering detailed terpene analysis and profiling to enhance the consumer experience of smokeable products.

  • Edible Manufacturing: Producing customizable, infused edibles that are both vegan and pectin-based, allowing for flexibility in flavor, color, and dosage.

GMP Compliance in Cannabis and Hemp: Frequently Asked Questions

What Are the Consequences of Non-compliance With GMPs?

Non-compliance can result in product recalls, regulatory penalties, and damage to your brand's reputation.

How Often Should GMP Audits Be Conducted?

Regular audits are necessary to ensure ongoing compliance, with at least annual reviews recommended.

What Are the Key Elements of a Quality Management System?

A comprehensive QMS includes documented procedures, quality policies, employee training, and continuous improvement processes.

How Can Manufacturers Ensure the Quality of Raw Materials?

Source materials from reputable, GMP-compliant suppliers and conduct thorough quality checks upon receipt.

What Are the Most Common GMP Violations in the Cannabis and Hemp Industry?

Common violations include inadequate quality control processes, poor record-keeping, and insufficient employee training.

Sources Used for this Article

24 views0 comments


Couldn’t Load Comments
It looks like there was a technical problem. Try reconnecting or refreshing the page.
bottom of page