This spring, Symeres Prague was audited by the national control authority SÚKL. After this audit, our GMP certificate was successfully renewed.
What is the GMP certificate, and what does it mean for Symeres and the Prague site?
GMP stands for good manufacturing practice and contains a set of guidelines, recommendations, restrictions, and regulations a company must adhere to, if they want to create active pharmaceutical ingredients (APIs) for drug testing in humans. The GMP certificate entitles the site to manufacture these APIs, enabling us to offer comprehensive services, from drug discovery to GMP production of batches for clinical trials. In Prague, we have offered this since 2014.
Our Prague team has extensive experience with working under GMP. The team of expert development and analytical chemists, complemented by the production team and QA, is fast and flexible. With two new reactor lines coming online soon, the capacity of the Symeres Prague site will expand further.