GMP Certification for THC Extraction, Hemp Products and More: A Step-by-Step Approach 

1, 2, 3 cGMP Certification Process


By Bre Whitehair - October 6, 2020

GMP Certification for THC Extraction, Hemp Products and More: A Step-by-Step Approach 
 
Not many hemp or marijuana companies have achieved GMP certification, perhaps because they don’t yet realize how much certification of their manufacturing processes can help their company be more efficient, create safer products and from a marketing standpoint, stand out above the competition.
 
In the United States, current Good Manufacturing Practices (cGMP aka GMP) are based on FDA regulations under Title 21 CFR. The federal guidelines provide requirements for manufacturers to ensure their products are consistently meeting quality and safety standards to protect consumers. We will go through the step-by-step process of how Allay Consulting can help secure GMP certification for your company and how Pinnacle Stainless helps clients achieve this goal. 
 
Allay Consulting is extremely knowledgeable on the topic of cGMP certification for cannabis companies. In this NCIA panel webinar “Service Solutions: How to Level Up Your Cannabis Business,”  Allay Founder and CEO Kim Stuck speaks about how cGMP and other practices can help your business on many levels.
 
Here are five steps a manufacturer of THC infused products or hemp products needs to take to obtain cGMP certification:
 
First Step – Ensure your facility meets the basic FDA requirements before moving toward GMP requirements. This includes items such as up-to-code hand sinks, 3-compartment sinks, smooth ceilings/walls/floors, etc.
 
Having UL-listed, commercial, and food-grade equipment is very important. Allay Consulting works with Pinnacle Stainless to assist clients in ensuring they have extraction and processing equipment that is approved and safe to use in a cGMP-certified facility.
 
Pinnacle Stainless will provide customers with needed documentation for equipment compliance such as:
  • User Requirement Specifications (URS)
  • Factory Acceptance Test (FAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Turnover Package
  • Pinnacle Stainless will provide continuous support with updated documentation if any revisions are made to your equipment


Second Step – Select a cGMP accredited certifying company. There are a few third-party companies that are actively certifying hemp and THC cannabis businesses. Keep in mind that although each cGMP certifying company abides by the FDA’s general requirements, each company may have its own additional requirements.
 
Third Step – Document all processes within the facility. Allay helps to compile the extensive amount of documentation required for cGMP compliance, such as standard operating procedures (SOPs) for product manufacturing, packaging and facility maintenance, among other processes. This is a huge undertaking for most companies—it can take 6-24 months to complete this step. This time is dependent on the manufacturing scope within the facility, and what all documentation the company already has on hand. Many companies hire a consultant to handle the heavy lifting. 
 
Fourth Step – Put all of the documentation 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 on any new expectations and process changes.
 
Fifth Step – Pass the cGMP certifying audit. After compiling SOPs and employee training on new processes is complete, you are ready for an audit by the selected certifying company. Usually the auditors 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 these objectives by achieving cGMP certification. The certifying process can be a daunting task, but is well 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 you can promote your company’s focus on creating safe products for your customers. 
 
Allay Consulting offers many other compliance offerings such as FDA, OSHA, and ISO 9001 and ISO 2200 Certification assistance as well. If you have any questions related to cGMP certification in THC and hemp product manufacturing, contact Allay here.
 
 
 
 
 
 

NOTES
   
Pinnacle Stainless, LLC was formed in 2016 by Zach Harris and Dan Burns. With vast manufacturing and engineering experience spent in equipment fabrication for FDA food, pharma and cryogenics, the founders transferred their knowledge and skillset into the new and emerging industry of cannabis and hemp extraction.  A passion for the industry and the ability to design and fabricate quality equipment, led to quick market adoption and brand recognition. First focusing on custom designed extraction equipment, in late 2017 the company moved towards standardized skid-based solutions. Pinnacle’s primary equipment offering utilizes ethanol to extract cannabinoids from the biomass. As a result of the three-part process, extraction, filtration and solvent recovery, the final product that is created is winterized cannabinoid crude oil.
With the vision of future FDA regulation and safety in mind, the equipment meets cGMP (current good manufacturing practices) standards and is peer reviewed by a third-party engineering firm.  Like many start-ups, Pinnacle began in the founder’s garage, but quickly moved to their first commercial shop only a few months later. In October 2019, they purchased a 30,000 sq. ft. building to allow for administrative, fabrication, and R&D expansion.  
 Pinnacle Stainless founders recognized a need in the market for high quality, food grade and safe extraction equipment to help bring GMP manufacturing to an immature cannabis and hemp industry. Born in the food industry creating quality equipment for production, our founders created Pinnacle Stainless. Pinnacle Stainless founders recruited top experts in manufacturing, engineering and extraction to build a highly qualified team to produce the best, most innovative equipment in the market. Pinnacles engineering team has over 30 years of experience in the food, beverage, and cryogenic industries.
We create off the shelf packages, add-on’s and custom units for every need of extraction. In addition to producing the best in class extraction equipment, we have a second to none training program and customer service team. We manufacture all our equipment in Denver Colorado and welcome tours of our facility.
Our goal is to offer premium customer service and tech support. We provide both on-site and virtual training services to make sure you know how to operate our systems safely and correctly.
For More Information 
Contact us
720-609-2968 or 
sales@pinnaclestainless.net
 
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