Introduction

When innovation outpaces regulation, the opportunity for risks run high. This seems to be the case for the growing legal cannabis industry, with states continuing to post record-breaking cannabis sales. High consumer demand has fueled the speed at which organizations provide cannabis and cannabidiol (CBD) products and services. Not only must cannabis and CBD producers, distributors and labs meet growing demand, they must also ensure they are safe for consumers.

The United States Food and Drug Administration (FDA) is the government agency responsible for protecting consumer safety and public health by ensuring the safety and efficacy of drugs, food, medical devices, cosmetics and more. This is done by regulating drug manufacturers’ compliance with its Good Manufacturing Practice (GMP) regulations. While this industry does not have specific GMP guidelines, there is still a need for quality assurance in the growth, manufacturing, packaging, and distribution of cannabis and CBD products.

 

Cannabis, CBD and Good Manufacturing Practices (GMP)

Since cannabis remains illegal at the national level, federal regulations specific to the cannabis and CBD industry are still being developed. However, a growing number of manufacturers, suppliers, extraction and testing labs are staying ahead of federal cannabis regulations by complying with Good Manufacturing Practices (GMP), in addition to their state laws.

 

The FDA’s current guidelines for good manufacturing practices provide the framework for a system of processes and documented procedures to ensure the safety and quality of drug products. Good manufacturing practices ensure that drug products are consistently produced in a controlled environment to ensure their intended use. By operating in compliance with GMP regulations, organizations can ensure the safety, consistency and efficacy of products to keep consumers safe.

 

Overview of Good Manufacturing Practices

The regulations for GMP compliance for drugs and finished pharmaceuticals are described in Title 21 of the Code of Federal Regulations (CFR) Part 210 Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs and Title 21 of CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals. The regulations describe the minimum requirements for the methods, facilities, and controls that should be used in the drug manufacturing, processing, and packing processes. The GMP requirements are written in a way that allows each manufacturer to decide how to best implement the required controls.

Organizations that are considering GMP compliance should be familiar with the elements of the regulation:

• Subpart A – General provisions

• Subpart B – Organization and Personnel

• Subpart C – Buildings and Facilities

• Subpart D – Equipment

• Subpart E – Control of Components and Drug Product Containers and Closures

• Subpart F – Production and Process Controls

• Subpart G – Packaging and Labeling Control

• Subpart H – Holding and Distribution

• Subpart I – Laboratory Controls

• Subpart J – Records and Reports

• Subpart K – Returned and salvaged drug products

 

Benefits of GMP for the Cannabis Industry

While compliance to GMP requirements for cannabis products may not be mandated, operating in compliance to GMP regulations brings several benefits to cannabis and cannabidiol (CBD) organizations. Organizations who successfully comply with GMP regulations experience several benefits, including:

• ensuring the health and safety of consumers

• complying with laws and regulations

• ensuring the safety and efficacy of cannabis and cannabidiol (CBD) products

• reducing consumer risks

 

How to Implement GMP Regulations

Implementing and adhering to GMP regulations can be difficult, but highly rewarding. The following are a few general steps organizations should consider as they work to comply with GMP regulations:

1. Become familiar with the GMP regulations by reading Title 21 of CFR Part 210 and Part 211.

2. Perform a gap analysis of your operations to GMP regulations.

3. Design and develop the required documentation to meet GMP compliance. Learn how our consultants can assist with implementing the applicable regulatory requirements and management system(s) to ensure compliance to cannabis and CBD good manufacturing practices.

4. Focus on implementing the GMP requirements.

5. Perform GMP audits and inspections.

6. Respond to any audit findings.

7. Upon successful implementation, your organization will achieve GMP compliance.

 

Conclusion

While federal guidelines for the cannabis and CBD industry are still under development, manufacturers, suppliers, extraction and testing labs are not just waiting on standards. Organizations in the cannabis and CBD industry are exercising due diligence by implementing GMP regulations. These organizations recognize that producing safe and effective products for consumers is vital to the future of their industry. Are you looking for GMP consulting services? Our consultants can help you implement GMP requirements to ensure effective, efficient and compliant operations. Contact us to learn more.

 

Author

Victoria Ontiveros | Marketing Coordinator 

Victoria focuses on creating quality educational content that provides value to current and potential clients. By collaborating with members of leadership and sales, she is able to develop informative articles that answer common questions and connect with current trends.

Victoria earned her Bachelor of Science in Sociology with an emphasis in communications from Texas A&M University.