iBET renews GMP certification
iBET's Analytical Services Unit renewed its Good Manufacturing Practices (GMP) certification for Human Pharmaceuticals and Experimental New Drugs, by Infarmed (the national agency that regulates and supervises the drugs sector and health products in Portugal). This is the third consecutive renewal of this certification, which is very important for strengthening and international recognition of iBET, namely its Analytical Services Unit for the work developed in quality control of drugs and experimental drugs, for human use.
The inspection activities carried out by Infarmed are aimed at verifying the compliance with Good Manufacturing Practices, in accordance with national/community standards established by the European Commission in the different areas of intervention, by the European Medicines Agency (EMA) and by the International Pharmaceutical Inspection Co-operation Scheme (PIC/S) Services. As a result of the inspection, and when in accordance with the requirements of Good Manufacturing Practices, three certificates are issued: a Manufacturing Authorization, a GMP Certificate for Human Pharmaceuticals and a GMP Certificate for Experimental Drugs.