Recipharm’s cGMP compliant facilities are equipped with state-of-the-art technology to ensure rapid and accurate product quality control. We perform release analyses for EU and US regardless of where the product is made.
Our experts are well-trained in approved methods and procedures to guarantee the maximum reliability of the sampling, testing and environmental controls.
We validate test methods to meet GMP purposes, ensure records comply with the ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principles and that they 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 (MA) or clinical trial authorisation.