Good Manufacturing Practices (GMP) in the Cannabis Industry

Good Manufacturing Practices (GMP) are essential to manufacturing operations and applicable to various industries, including medical goods and food products. 

Even the cannabis industry has highly regulated legal markets worldwide that require products to be cultivated, manufactured, and distributed under global standards. If you plan to enter the cannabis industry and already have experience with GMP, you're ahead of the curve. 

However, if you're unfamiliar with GMP certifications in the cannabis industry, it's important to understand its requirements to avoid potential issues. Although many legal cannabis states and countries do not currently require GMP for cannabis, it is likely to become a requirement in the future –  preparing your business is beneficial.

Understanding GMP in Cannabis 

According to the World Health Organization (WHO), Good Manufacturing Practice defines production and quality control measures. It encompasses clearly defined, validated, reviewed, and documented processes necessary for production and testing. 

This includes ensuring that personnel, premises, and materials are suitable for producing pharmaceuticals, biologicals, and vaccines. Applying GMP to your cannabis business means your customers can rely on: 

• Quality, 
• Safety
• Consistency
• Assurance that the purchased products produce desired and expected effects

As consumers become more educated about their preferences, it's inevitable that they will be looking for products with GMP certification, in the same way they look for organically and responsibly grown fruits and vegetables. 

On the business-to-business side, many companies have already established guidelines requiring GMP certification from operators they do business with. The trend toward certification indicates that standardization is not far off for the industry. Like longstanding established industries, cannabis aims to grow an educated and responsible consumer base.

What are the Key Elements of GMP?

When evaluating your cannabis manufacturing facility in terms of GMP, several factors must be considered: 

1. Maintaining proper hygiene and ensuring regular facility cleaning is crucial. 
2. Providing thorough training to your employees to adhere to documented procedures is critical in minimizing risks during production and distribution.
3. Explicitly outlining procedures and defining key terminology will help establish control over product outcomes. 
4. Ensuring the process for reporting chains and efficient mistake identification to specify correction processes are also important.

Establishing good manufacturing practices for your cannabis business early on is highly recommended. If the cannabis product that your business produces or sells enters the market, there should be clear documentation of the product’s journey from seed to sale. Establishing protocols after the fact will lead to more mistakes and potential recalls. 

On the other hand, Quality Assurance and Quality Control (QA/QC) is a significant part of that journey – it’s a set of procedures used to measure and assure the quality of a product. 

From the perspective of the cannabis industry, it is the direct responsibility of cultivators and manufacturers during production, and dispensary retailers during sales.

For example, if you are a retail operator, you won’t have the same commercial standards to follow as a cultivator. Still, you will need guidelines for the cannabis products you purchase to ensure quality items for your customers.

Many jurisdictions still do not require GMP certification for cannabis businesses. The United States continues to classify cannabis as a Schedule 1 substance making it illegal and preventing federal agencies, such as the Food and Drug Administration (FDA), from participating in the regulatory process. 

With that said, ensuring quality, safe, and consistent products has thus become the regulatory responsibility of individual state departments and agencies. Although regulations vary from state to state and may not require GMP certification, your cannabis business can take the initiative and prepare for a future GMP certification. 

Using GMP guidelines now will help the development of quality products and safe manufacturing processes, which can reduce potential liabilities and build your brand’s reputation. This certification will cost more in the future to redevelop all of your business SOPs and train staff on new systems to ensure regulatory compliance in cannabis. Implementing these practices and guidelines now will save you time and money in the long run. 

There are plenty of established industries to model your GMP practices and procedures after. However, there are some nuances to consider within the cannabis industry. If you’re not familiar with navigating these or a GMP certification in general, then be sure to utilize the services of a professional cannabis consultant. 

This will save you time, money, and a bureaucratic headache. Knowing what will be expected of your business and preemptively implementing those expectations will help you secure a stable and scalable operation.

Going Beyond Quality Testing

GMP involves more than simply checking product quality at the testing level. It extends to record-keeping, staff training, a hygienic work environment, product development, and materials. Neglecting any of these areas, especially in the context of cannabis, can lead to unsafe products entering the market and increased costs for business owners. 

Implementing GMP at all levels of cannabis production and manufacturing can save your business money and protect consumers from different potential health risks. Having a cannabis company or product GMP certified ensures compliance and consumer safety while adding value to your business and expanding its potential.

The Importance of GMP Certification in International Markets

Many countries, particularly in the European Union, require cannabis companies to be GMP compliant. Germany, for example, does not import cannabis products unless they are produced at GMP-compliant facilities. If you plan to enter your cannabis business to markets overseas, understanding the significance of GMP and other regulatory standards in your chosen location is critical.

GMP Applications in Different Cannabis Operations

Overall, good manufacturing practices are crucial for every: 

• cannabis product manufacturer 
• distributor 
• Cultivator
• dispensary operator
• retailer

Each stage of the product's journey, from seed to sale, should be documented. While the specific GMP requirements may vary between these operations, adhering to guidelines ensures quality, safety, and consistency for customers and helps meet their expectations.

Preparing for a Regulated Future in the Cannabis Industry 

As cannabis consumers become more educated and responsible with their product purchasing, they will likely seek products with GMP certifications. Business-to-business relationships are also trending toward requiring GMP certification from operators. 

While some jurisdictions do not currently mandate GMP certification for cannabis businesses, implementing GMP guidelines now will save time and money in the long run. It will also help develop quality products and safe manufacturing processes that will help you build a reputable brand. You can secure a stable and scalable operation by preemptively anticipating and adopting future expectations.

Obtaining a GMP Certification

The process of obtaining GMP certification depends on your market. While U.S. federal regulators do not provide GMP certification for businesses based in the country, it’s important for cannabis companies to adopt these best practices early on. 

These practices aid in developing quality products, safe manufacturing processes, and reducing potential liabilities. In the European Union, national authorities inspect manufacturing sites within their territories to determine GMP compliance. 

For manufacturing sites outside the European Union, inspections are conducted by the competent national authorities of the Member State where the EU importer is located. Mutual recognition agreements (MRAs) between the European Union and other countries can also impact inspection processes. It's important to note that GMP regulations are broadly defined, and interpretation is left to the regulating body.

Developing Good Manufacturing  Practices for Your Cannabis Business 

Implementing GMP requires your cannabis company to establish a thorough development of practices and record-keeping. Standard Operating Procedures (SOPs) should be created for each stage of operation to ensure compliance with GMP guidelines and standards. When your cannabis business is ready to develop GMP for your operation, consider the following: 

• Establishing a Quality Management System 
• Designating a professional and experienced “Qualified Person” Staying updated on GMP certification requirements and cannabis regulations. 

Seeking a Professional Cannabis Consultant for Your Business? 

Navigating the complex landscape of cannabis regulatory compliance,  especially when operating in multiple states or countries, can be challenging. To ensure success, it's advisable to seek the assistance of professional cannabis consultants who’re familiar with GMP certification. 

They can provide guidance, save time and money, and help you avoid bureaucratic obstacles. Taking proactive steps now will position your business for stability and scalability as the industry moves towards standardization.

The Role of 3C Consulting

In the cannabis industry, adopting GMP practices is essential for ensuring product quality, safety, and consistency. While GMP certification is not currently required in all jurisdictions, it's wise to implement these practices proactively to prepare for future regulations and consumer expectations. Following GMP guidelines can reduce liabilities, build a reputable brand, and open doors to international markets. By partnering with a cannabis consultant about establishing these good manufacturing practices for your company,  you can navigate the complexities of GMP certification and position your business for long-term success. 

If you require help obtaining GMP certification and staying ahead of the curve, 3C Consulting can assist you. Our company has a proven track record of helping operators obtain GMP certification and other certifications for important cannabis industry standards, such as Good Agricultural and Collection Practices and Good Accounting Practices. 

Our experienced team of cannabis industry experts  works closely with clients to ensure successful inspections and maintain certifications without fail. For more information on GMP certification, feel free to contact 3C Consulting.