Our cGMP compliant facilities are equipped with state-of-the-art technology to ensure rapid and accurate product quality control. Release analyses for EU and US is performed regardless of where the product is made. Our experts are competent and well trained on approved methods and procedures to guarantee the maximum reliability of the sampling, testing and environmental controls.
Test methods are appropriately validated to meet GMP purposes and records comply with the principle of ALCOA and are formally assessed against specification. Any deviations are fully recorded and investigated before material approval and product release.
Strict collaboration is in place with QA/QP to guarantee full compliance with the requirements of the marketing authorisation or clinical trial authorisation.