Quality Assurance
Our aseptic manufacturing site is a multi-use, multi-product facility with regulatory controls, policies, and procedures to ensure that the highest quality standards are always met.
Formatech has undergone hundreds of successful client audits as well as comprehensive inspections by regulatory agencies: the FDA and the MHRA. We have had two successful inspections by the FDA yielding no 483s. The MHRA has successfully inspected our facility three times; we are certified to manufacture aseptically-processed clinical supplies to EU cGMP standards.
Our quality systems are designed to support manufacturing, product release testing, and product stability programs. These quality systems consist of three key programs:
To request more information on Formatech and our services, please click here.
Formatech has undergone hundreds of successful client audits as well as comprehensive inspections by regulatory agencies: the FDA and the MHRA. We have had two successful inspections by the FDA yielding no 483s. The MHRA has successfully inspected our facility three times; we are certified to manufacture aseptically-processed clinical supplies to EU cGMP standards.
Our quality systems are designed to support manufacturing, product release testing, and product stability programs. These quality systems consist of three key programs:
- Documentation control: this program consists of master controlled documents with restricted access
- Validation: these programs are designed to cover our facility, equipment, processes and include supplier audits
- Personnel training: our training programs include cGMP, task specific, and safety training
To request more information on Formatech and our services, please click here.
“Quality is not an act,
it is a habit.”
Aristotle