According to outstanding laws and regulations (Law on Medicines, Pharmacy Act, Regulation on Medicine and Medical Products Distribution), Galen products which are produced in the Galen laboratory are subject to quality control. Uncontrolled medicine is potentially of low quality and represents a risk for the health of the patient. Risks in the medicine production and/or Galen products are:
Therefore, with the intent of patient health protection, the following analyses are conducted:
Our common goal is to set a system of quality with Good production and laboratory practice application and develop and put on the marker quality, safe and effective products.
With that goal in mind, the Quality control laboratory:
For the purposes of pharmaceutical – non-clinical examinations of feedstock and products, the following is applied:
Methods prescribed in Pharmacopoeias are conducted (Croatian HRF, European Ph.Eur., Yugoslav Ph.Jug, British BP, American USP/NF, Japanese JP, international Int.Ph…)