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 been inspected three times by the FDA and three times by the MHRA. The MHRA has certified that our facility and controls are compliant with EU cGMP standards for the manufacture of aseptically-processed clinical supplies.
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 been inspected three times by the FDA and three times by the MHRA. The MHRA has certified that our facility and controls are compliant with EU cGMP standards for the manufacture of aseptically-processed clinical supplies.
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