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What are the Common Quality Assurance Certifications Used in Cannabis
The key quality standard certifications that cannabis companies currently seek to achieve are GACP, GMP, EU-GACP/GMP, and CUMCS-GAP.
Good Agricultural and Collection Practices (GACP)
The GACP certification (Good Agricultural and Collection Practices) ensures that medicinal plants, including cannabis, are produced and handled appropriately to maintain their quality and safety. Cannabis GACP typically pertains to cultivation, harvesting, and collection of cannabis plant material. Generally, this certification involves all activities before the drying stage.
Good Manufacturing Practices (GMP)
The GMP certification (Good Manufacturing Practices) covers the manufacturing processes and facilities, ensuring that products are produced according to detailed quality standards. It encompasses aspects such as facility cleanliness, personnel training, premises and equipment maintenance, quality system, and record-keeping. The GMP certification covers everything from the drying stage of cannabis cultivation to all manufacturing processes onwards.
This certification is generally a standard in the pharmaceutical and food industries; however, some cannabis companies have either chosen to, or been required to obtain this certification.
European Union GACP & GMP (EU-GACP & EU-GMP)
EU-GACP and EU-GMP are the European Union’s specific regulations and guidelines for Good Agricultural and Collection Practice (GACP) and Good Manufacturing Practice (GMP). These standards apply to medicinal products, including the manufacturing of products containing medical cannabis as a starting material and as an active pharmaceutical ingredient intended for human use within the EU.
An EU certification is required for companies seeking to export cannabis and cannabis-derived products into or out of the EU. It is a particularly coveted certification by many cannabis companies, including those in Canada looking to diversify and expand their market capture.
Control Union Medical Cannabis Good Agricultural Practice (CUMCS-GAP)
Control Union Medical Cannabis (CUMCS) Good Agricultural Practice (GAP) standard is a recognized and accepted program by the Israeli Medical Cannabis Agency (IMCA) – Ministry of Health, for all imports of medical cannabis into Israel. It is based on the principles of GACP from other recognized organizations like the World Health Organisation (WHO) guidelines, European Medicines Agency (EMA) GACP, guidelines of the Dutch Government for Cannabis for Medical Use, and International Standard for GACP.
Like the other quality standards mentioned, CUMCS-GAP focuses on ensuring that cannabis is cultivated, harvested, processed, and distributed according to best practices. This ensures the highest product quality and safety in compliance with Israel’s regulations. The CUMCS-GAP standard covers various aspects of cannabis cultivation, including site selection and preparation, cultivation practices, harvesting and post-harvest handling, and record-keeping. By obtaining CUMCS-GAP certification, cannabis producers in Israel and those seeking to export to Israel can demonstrate their commitment to producing high-quality, safe products to be exported to Israel.
What’s Required & How Much Do These Certifications Cost?
To obtain GACP, GMP, EU-GACP/GMP, or CUMCS-GAP certification, companies must follow specific guidelines and standards set forth by regulatory bodies such as Health Canada, FDA, EMA, and relevant national authorities. The requirements to receive any of these certifications depend on how many applicable standards have already been proactively incorporated into the facility design, equipment, processes, systems, and more.
Some areas where companies often need support include implementing appropriate quality management systems, qualifying and validating equipment and processes, preparing site master files and SOPs, establishing product readiness, and preparing for the inspection along with staff training.
The costs associated with getting a certification can vary significantly depending on the size of the operation, the complexity of the processes, products, and strategy involved that define the project scope. As a result, costs generally range from tens of thousands to hundreds of thousands of dollars, considering expenses related to facility modifications, equipment upgrades, training programs, lab testing, consultancy services, and regulatory licensing fees.
Is it Always Beneficial to Get Certified?
Businesses need to be realistic about what they can achieve. Obtaining GACP, GMP, EU-GACP/GMP, or CUMCS-GAP certification requirements can be a significant investment for a lot of businesses, both in terms of time and money. It’s also important to be clear and honest about the goals of obtaining these certifications to ensure the proper strategy and partners are identified.
With this in mind, the advantages can largely outweigh the costs. Certification can enhance a company’s reputation, improve product quality and consistency, increase market access, establish control in the supply chain, and importantly increase profit margins (compared to not being certified and having another certified company “GMP wash” your products for you).
While GACP and GMP are not yet universally enforced in all countries where cannabis cultivation and manufacturing are legal, These quality certifications will likely become standard practice to establish national and international uniformity. Following internationally recognized standards can differentiate a cannabis product from others, and position it as superior to non-GACP/GMP produced cannabis. It’s never a bad idea to get a GMP certification for medical cannabis or recreational cannabis.
How can CannDelta Help?
CannDelta offers GACP, GMP, EU-GACP/GMP, and CUMCS-GAP certification support and audit services for cannabis companies. We can ensure your business and products meet the standards for the key markets in North America, Europe, Israel, Australia, and other countries where GACP and/or GMP are required and necessary for their cannabis operations.
Other related key services we provide include global strategy support, risk assessments, pre-inspection preparation, regulatory authority inspection coordination, site validation, change of control management, supplier audits, quality management system (QMS) development, product quality and testing support, standard operating procedure (SOP) writing, and staff training and education. As part of our project-scoping process, we’ll ask several critical questions to better understand the client’s needs and objectives for the desired certification(s).
Frequently Asked Questions
How do I Get a GAP Certification?
Farmers and cannabis cultivators must pass the USDA GAP audit to verify they meet GAP certification requirements and confirm their compliance with Good Agricultural Practices. To apply for an audit, you will need to determine which kind of application you need and review the GAP certification requirements. The type of application you submit will depend on the type of operation you have.
How do I get a GMP Certification?
You can get a GMP certification for medical cannabis or recreational cannabis cultivation, processing, and manufacturing facility, or any other facility that requires a GMP certification by passing your GMP certification audit. This will involve preparing for the audit by understanding what needs to be changed in your facility to meet GMP standards, develop the necessary operating procedures, and preparing to succeed and demonstrate compliance during the audit.
Why do I Need a GMP Certification for Cannabis Products?
Applying for a dispensary license in New York requires that you are eligible to apply for the license, and can provide a variety of other components. You must have information about the premises you are licensing, financial statements, business plans, operating procedures and more. You can complete the application using the Office of Cannabis Management’s (OCM) application portal.
Why do I Need a GMP Certification for Cannabis Products?
GMP is the leading quality standard in the cannabis industry. In fact, several states have already mandated GMP certification for cannabis manufacturing. This is because GMP ensures quality standards that will keep consumers safe and minimize risk involved during production.
