Asterra Labs has constructed a 10,000-square-foot manufacturing facility in the central Research Triangle region of North Carolina. This facility houses manufacturing and warehousing facilities that meet the high standards outlined in current Good Manufacturing Practices (cGMPs) as defined by the U.S. Food and Drug Administration.
Construction, Equipment and Cleaning
Asterra Labs maintains stringent control over the construction, operation and cleanliness of our facilities. Because of our decades of experience in the prescription drug industry, we believe this approach is the only way to consistently deliver high-quality and pharmaceutically pure products.
Construction materials used in our building and manufacturing suites are pharmaceutical-grade. Each manufacturing suite is conditioned with climate and humidity-controlled HEPA-filtered air. The rooms are pressurized to prevent contamination from outside sources, such as dirt or dust.
Equipment used to make our tablets is constructed of pharmaceutical-grade steel and is subjected to a rigorous preventative maintenance schedule. Machines are regularly calibrated and challenged to meet their operating specifications. Lubricants and manufacturing implements are all food- and pharmaceutical-grade.
Everything inside our facilities is routinely cleaned and inspected by our Quality Assurance department. Only screened, trained and qualified manufacturing personnel are permitted to enter the area — which they do by passing through an airlock and donning personal protective equipment (PPE) designed to protect both them and the products manufactured.
Why are such stringent controls important in the manufacture of CBD products?
Because the CBD industry is not regulated by the federal government or independent, third-party organizations, manufacturers are at liberty to set up their production lines any way they choose. This is not the case for products like food, prescription drugs, or even over-the-counter drugs like Tylenol or Benadryl. In the United States, foods and medications must adhere to specific regulations that ensure the public gets quality products and that no foreign substance is in them.
When we make our CBD products, we follow the same guidelines the FDA applies to prescription drugs — it is the responsible, ethical and safe thing to do. Most other CBD manufacturers cannot claim the same.
We believe strict FDA regulations on over-the-counter CBD products are coming — as well they should.
And when they do, Asterra Labs will be ready.
Because Asterra Labs has followed FDA guidelines from day one, we are absolutely confident that we are delivering a pure and high-quality product to our consumers.
FDA Requirements and cGMP
Most CBD products available on the market today are not made in an environment that would meet the FDA’s stringent expectations.
Any company claiming to be “GMP certified” is making a misleading claim. There is no such certification. Being cGMP-compliant, on the other hand, means adopting laws, principles and guidance from the FDA and being able to surpass an FDA audit and inspection.
You can learn more about what the FDA says about cGMP guidelines by clicking here.