Axil Scientific is now cGMP Certified!
Axil Scientific is proud to announce that we are now a cGMP certified contract manufacturer.
Our facilities have been assessed and certified by SOCOTEC Certification International as conforming to cGMP and customer requirements based on 21 CFR 820 for the manufacturing, kit assembly, and distribution of molecular biological reagents, buffers and culture media for the use in in-vitro diagnostic medical devices.
This certification assures proper design, monitoring, and control of our manufacturing processes and facilities.
To follow CGMP, it includes establishing strong quality management systems, using good quality raw materials, implementing robust operating procedures, meticulously screening and investigating product quality deviations, and maintaining reliable testing laboratories.
Put simply, a company must have:
- Facilities that are kept in good condition;
- Equipment that is carefully maintained and calibrated;
- Employees who are qualified and fully trained and;
- Operating procedures that are reliable and reproducible.
Investing in our manufacturing capabilities and qualifying as a cGMP certified facility is a key milestone to our goal of growing our contract manufacturing services. This will allow us to increase our product offerings and open new market opportunities.
Click here for more on our quality standards.