Manufacturing and Safety

Every product manufactured by Asterra Labs meets the highest standards of quality, purity, and safety. Customers can be assured they are getting exactly what is on the label.

When it comes to manufacturing, we took great care to construct our facilities to meet or exceed the same cGMP guidelines followed by the regulated pharmaceutical industry, which is regulated by the U.S. Food and Drug Administration (FDA).

Here are three key ways in which Asterra Labs differentiates itself from other CBD manufacturers and assures that we deliver quality, purity and safety in every tablet:

Quality control of ingredients.

Every ingredient that goes into each Asterra Labs product is tested for purity and conformance to its specification.

CBD does not currently have a specification published in the United States Pharmacopeia (USP). The USP is book of standards recognized by the FDA as acceptable for determining the safety and purity of specific ingredients.

Asterra Labs stringently tests its CBD. Read more about our lab tests and why we do them.

All other ingredients used by Asterra Labs meet the requirements published in the USP.

We source our materials only from cGMP-compliant suppliers. This means each supplier is subjected to a stringent qualification and auditing process to ensure their facilities and processes deliver high quality, safe and pure materials. In fact, Asterra Labs works with many of the same suppliers serving the prescription pharmaceutical industry.

To ensure materials weren’t compromised during transit, each one is inspected at Asterra Labs before we accept it into our facility. And only when material is tested and inspected is it released for manufacturing.

Quality control of manufacturing.

Products at Asterra Labs are developed and manufactured within a cGMP compliant environment. Rooms and equipment are meticulously cleaned for a controlled, dust-free environment.

Each step of the manufacturing process is documented on a controlled batch-record. This document instructs the highly trained manufacturing specialist as to what parameters are required; it also is where Asterra Labs records data on all critical control points and in-process controls – weights, mixing times, environmental conditions, speeds, etc. If the process does not conform to the batch record, the product is rejected.

Quality control of the finished product.

Every lot of product is tested extensively. Finished goods testing and the release of products to the market involve all functional teams. At Asterra Labs, this includes operations, quality control — not not only the independent laboratory, but also our internal expertise and oversight — and, finally, quality assurance. Working together, they ensure safety and purity throughout the process from beginning to end.

After production, samples of each batch are sent to an independent laboratory for testing. Once acceptable test results are obtained and batch records have been reviewed and approved by QA, the final product is released for shipment. All laboratory test results are available for our customers to review.

 

Asterra Labs was formed to do better.

To innovate, develop, and manufacture a pharmaceutical-grade line of cannabinoid products.