Good Manufacturing Practice Certification: Why Cannabis Companies Should Pursue It Now
August 10, 2020
For cannabis companies, creating high quality consistent products is key to standing out in a crowded consumer market. One way to stand out is to become cGMP certified. As the market matures and you set your eyes on expansion in new markets, preparing for future regulations will help ensure success. Recently the FDA provided aDRAFT GUIDE mentioning cGMP, indicating this is the wave of the future for the cannabis industry, not only in the US but also international markets.
What exactly is GMP? GMP, also referred to as cGMP, stands for current Good Manufacturing Practices and is a certification held at the processingfacility level. Operating a facility that abides by GMP standards ensures products are safe, fit for purpose, high quality, andconstructed consistently for consumer use. The process of becoming cGMP certified requires an audit of all aspects of a facility's production, including raw materialspecifications and storage, equipment quality and safety, production environment, finished goods storage, personneltraining, and personal hygiene. This same process is used in cosmetic, food, and pharmaceutical industries to guarantee safe consumer products.
How does it help your company? The primary purpose of becoming cGMP certified is to ensure the quality and safety of your products. It also opens opportunities to make your company more marketable and ready for expansion into other distribution channels. Consumers and retailers alike want to support companies they know they can trust. Retailers want to sell and distribute brands that have high standards and values, and many times require third party audits of manufacturing facilities.
How to get certified? The process of becoming certified is coordinated through a third-party auditing firm such as NSF, SQF, or AIB International who will guide you throughout the process.
Preparing for the audit. Prior to engaging in an inspection from an auditor, you will need to make sure your processes, documentation, and training are in place and meet cGMP standards. This entails creating a Quality Management System (QMS). Your QMS will need to cover all aspects of a facility's production, including raw materialspecifications and storage, equipment quality and safety, production environment, finished goods storage, personneltraining, and personal hygiene. If you are new to quality standard certifications, utilizing a cGMP consultant to help create documentation and processes will ensure you are prepared prior to your audit.
Remember, the key to passing an audit is preparation, preparation, preparation. Have your facility assessed. Inspectors will evaluate your facility, equipment, and quality assurance methods to ensure they meet cGMP standards. After reviewing, the inspector will create a detailed list of corrective actions that you will need to implement. If these are minor changes, you will pass the audit and provide proof of completion of the corrections at a later date. If they are major corrections, you may be required to schedule a re-audit of the facility.
Evaluating your equipment supplier. One major investment in your cGMP facility is going to be your equipment. It’s important to vet your equipment suppliers and ensure that your equipment is cGMP compliant. Pinnacle Stainless assists the customer in becoming certified by providing the following documentation pertaining to our cGMP compliant equipment: User Requirement Specifications (URS), Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ) Turnover Package, and continuous support with updated documentation if any revisions are made to our equipment. Now that you are GMP certified, it’s time to market to the world, to current customers, and to your supply chain to let them know your products meet high quality and safety standards. Show off your brand credibility and reputation. Fasten your seatbelts and get ready for the ride.