Cannabis GMP Certification
To become Good Manufacturing Practice (GMP) certified in the Cannabis industry organizations must meet a high level of compliance through independent evaluations of standard operating procedures, facility inspections or audits, and have put in place specific company GMP training systems and GMP-related documentation. A key component of any quality assurance plan GMP practices are vital components of ensuring the safety and quality of your company during the production of manufactured goods.
GMP certification itself describes the minimum standard that a medicine manufacturer must meet in their production processes. Under this definition, only medical cannabis companies would be concerned about the standard. However, possessing the certification opens new business opportunities, and makes it possible to receive a higher price for products from discerning clients. Obtaining a certification and adhering to it also helps minimize the risks now and in the future from any product misuse or tampering as the GMP process does involve traceability and ensuring that products are of consistently high quality, appropriate for their intended use, and meet the requirements of the marketing authorization or clinical trial authorization that doctors depend on when prescribing.
A GMP certification is the minimum standard to which cannabis companies with international ambitions need to hold themselves to. To open all markets, we recommend EU-GMP certification. That said, GMP standards are costly to implement in the start-up phase, but the cost is quickly offset by the possibility to receive a higher price domestically, lower risks, and access to international markets that potentially offer a much larger increase to the return on investment.
GMP in Cannabis and the U.S.A
While the US market is still operating on a state-by-state basis, and federal legalization remains a ways off, federal agencies have not yet developed standards. Under normal circumstances, the FDA establishes GMP regulations for products including foods, human and veterinary drugs, medical devices and products, cosmetics, dietary supplements, and tobacco products. Despite cannabis being a consumable, the lack of federal legalization precludes the FDA from established regulations. This market gap is one to be cautious of: Once the FDA gets involved it is highly unlikely that they will tolerate an adjustment period. Your company is either compliant or non-compliant. So, even if the FDA currently has no guidelines for cannabis-related products, forward-thinking companies that want to remain in business post-legalization are seeking GMP / cGMP and in some cases EU-GMP certifications. The period of no federal regulations will be over in the blink of an eye as the government is required to guarantee the population’s safety.
compounding industries.
If you are doing business in the USA today you don’t need GMP certification. But consumers are becoming more educated, and discerning all the time. Ignoring the opportunity to become certified now increases the cost to your business later, and may result in business operations as all your competitors rush to be certified by a limited number of certifying agents. In California alone today there are hundreds of producers who overnight will require certification. Businesses that are not certified will sit on the sidelines, missing sales as they wait to be processed. Or, they could start the process now, and have a huge head-start on everyone else.
What GMP Certification Involves
GMP certification, as well as cGMP and EU-GMP certifications, are not just about processes and procedures. They also involve the quality and condition of the facility, and always include a basic set of requirements that cover:
- Monitored environmental conditions.
- Air quality and particle monitoring systems that also monitor temperature, humidity, and air pressure differential, with alarms if limits are exceeded.
- Within the certified areas, there should be negative and positive air pressure areas maintained, and the air has to be supplied into rooms through the filters.
- Microbiological monitoring.
- Demonstrate airflow patterns do not present a contamination risk.
- Doors should be designed to that staff follow specific paths in and out of rooms, areas, and the facility as a whole. There are no two-way doors.
- It also cannot be possible for more than one airlock door into a space to be opened at the same time.
- Clean area entry must also be via airlocks for anything (personnel, equipment and product materials ) to enter and depart areas within the facility.
- Each step of production (extraction through the manufacturing of the final consumable product) must be carried out in separate & dedicated spaces.
- All exposed surfaces in the facility must be smooth, impervious, and unbroken, floors cannot have 90 degree corners where they meet walls, etc.
- All shelves, product retention areas etc., need to be kept to the minimum required by production.
- Clean areas must be consistently maintained to the standards defined in the regulations and in the facility’s SOPs.
Corporate Benefits to GMP Certification
Certification will not just open the doors to new or ongoing revenue, it also involves putting in place a comprehensive and complete training process for everyone in the company, and ensuring everyone follows best practices for producing your product. This means training time is reduced and your staff can speak more authoritatively with any customer about the product, and the full provenance including how it was grown, where, and what makes it different and special. A well-trained staff member is also less likely to leave your employment, and lower turnover has a direct benefit to your bottom line.
GMP certification is a source of pride in your team. It’s also a great statement about your firm’s priorities when attracting new staff. People want to associate with quality, to have pride in their work. Holding a GMP certification has a myriad of benefits.
GMP certification is not easy to receive. It’s a long process that does require the full participation of your organization. It’s not as if only one part of the company gets certified, it has to be company-wide. Good guidance is key to getting through. the process quickly and efficiently. The first time through there are a tremendous number of unknowns that you wish you were aware of. An experienced guide will help you avoid mistakes and get through the certification process efficiently. They can also provide or recommend ongoing Quality Assurance leadership to help maintain the processes and adherence to retain certification.
Other certifications to learn about and consider:
- Cannabis Industry Certifications
- Good Agricultural Collection Practice – GACP
Other certifications that would be helpful, and whose processes definitely should be considered are:
- Global Certifications of relevance:
- ISO Certifications: ISO-9001; ISO-13485; ISO-14001;