Allay Consulting July Newsletter: How to Gain GMP Certification
How to Gain GMP Certification
Not many hemp or marijuana companies have achieved GMP certification, perhaps because they don’t yet realize how much GMP certification can help your company be more efficient, create safer products and from a marketing standpoint, and stand out above your competition. Current Good Manufacturing Practices (GMP) is based on FDA regulations under Title 21 CFR in the US. The set of guidelines provide requirements that a manufacturer must meet to assure that their products are consistently high in quality and safety = focus on consumer safety!!
Allay Consulting can help cannabis companies gain cGMP certification and is extremely knowledgeable on the topic. In this NCIA panel webinar “Service Solutions: How to Level Up Your Cannabis Business,” our Founder Kim Stuck speaks about how cGMP and other practices can help your business on many levels.
Here are abbreviated steps towards obtaining cGMP certification.
First Step – Ensure your facility meets the basic FDA facility requirements before moving towards GMP requirements. This includes having all FDA requirements including hand sinks, 3-compartment sinks, smooth ceilings/walls/floors, etc.
Second Step – select a cGMP accredited certifying company. There are a few accredited cGMP certifying companies who are actively certifying hemp and THC cannabis businesses. Keep in mind that although each cGMP certifying company abides by FDA cGMP requirements, each company may have their own additional requirements.
Third Step – Create a plethora of documentation per cGMP guidelines. This is a huge undertaking for most companies. For some companies, this is the most time-consuming aspect when preparing for the cGMP certification audit. Due to the large volume of SOPs and documentation needed, many cannabis companies hire a consultant to assist with completion of this step. It can take 6-24 months to complete all of the documentation required for cGMP certification. This time is dependent on the company, what all they have already completed, and what all processes take place in the facility.
Fourth Step – Dust those documents off and put them to use. Implementation is a vital step; most cGMP certifying auditors will make sure employees are following the SOPs and documents without deviation. Make sure all cGMP practices are finely tuned and are practiced habitually prior to the auditor visit. This includes training your staff of the new expectations.
Fifth Step – Pass the cGMP certifying audit. After creating plans, implementing plans, and employee training is complete, you are ready for an audit by the selected certifying company. Usually the auditor will find minor things that they want changed (this is normal) but they will still grant the certification if a corrective action plan is submitted.
Few cannabis companies have cGMP certification because it is designed to be difficult to achieve. Companies who truly value the quality and safety of their products can showcase this by achieving cGMP certification. The certifying process can be a daunting task, but worth the extra effort! Once your company is certified, you now have a competitive edge on other companies who have not put in the effort to achieve this certification and safe products for your customers as well. If you have any questions related to GMP certification or how to obtain this certification, please reach out to Allay Consulting.
“Allay Consulting is a proud partner of Cannabis Certification Council and the Cannabis Sustainability Symposium. Right now applications are open for speakers! If you have something you would like to present, please feel free to click the link to apply. Hope to see you there!
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