Our aseptic manufacturing site is a multi-use, multi-product facility with regulatory controls, policies, and procedures to ensure the highest quality standards.
Our facility has undergone hundreds of successful client audits as well as comprehensive inspections by regulatory agencies: the FDA and the MHRA. We are proud to announce that as a result of the MHRA inspection, Formatech has been certified to manufacture aseptically processed clinical supplies to EU CGMP standards.
Our belief that compliance must be practiced individually before it can be achieved corporately has empowered our personnel to take an active role in establishing and maintaining critical compliance programs.
Our quality systems are designed to support manufacturing, product release testing, and product stability programs. This quality system consists of three key programs:
- Documentation control: this program consists of master controlled documents with restricted access
- Validation: these programs are designed to cover facility, equipment, and processes
- Personnel training: these programs include CGMP, task specific, and safety training
