Our Quality Management system is developed on the principle as described in ICH Q10. The rules governing our Quality System refers the basic legislation as published in the “Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”.
Fully closed system ensuring patient safety
Since most of the Advance therapies are based on living cells they cannot be sterilized without dramatic loss of potency and thus require full aseptic manufacture. For that purpose, Glycostem has state-of-the-art facilities and equipment which are designed and constructed to meet relevant regulatory, health, and safety requirements. Besides that, we have an adequate number of appropriately qualified, trained, and experienced employees which is needed to assure product quality. On top, Glycostem manufacturing process is fully closed which is a huge advantage for final product quality and of course patient safety.
Inspected, verified and qualified
Within Glycostem, quality is an integrated component in the chain from the start of the incoming materials until the release of the final drug product for patient. The Quality System is governed by the Quality unit, with an on-site Qualified Person, and covers an independent Quality Control and Quality Assurance department that is able to test and release products for human use in the clinic trial.
The Dutch Authority (IGJ) issued our Manufacturing licence short after their GMP inspection January 2019 and certificate in November 2021. This shows that Glycostem has an adequate Quality System and allows us to manufacture Investigational Medicinal Products for our clinical trials.