Isotopia Molecular Imaging Ltd. is pleased to announce that the company’s nuclear pharmacy plant, located in Petach Tikvah, has recently received GPP (good preparation practices) certificate, under the guidelines of Procedure No. 135 “Proper Preparation Conditions at the Pharmacy – High-Risk preparations: Sterile and Aseptic preparations” of the Israeli Ministry of Health.
Procedure 135 is the Israeli interpretation of the PIC / s Guide to Good Practices for the preparation of medicinal products in Healthcare Establishments 1 March 2014. And the Current USP <797> Pharmaceutical Compounding- Sterile Preparations.
Isotopia’s nuclear pharmacy is the first, nuclear pharmacy, to receive such GPP certificate in Israel.
The certificate was obtained after a thorough quality audit, carried out by representatives of the Israeli Ministry of Health, in the pharmacy and its quality system.
The great success is the fruit of the enormous investment of Isotopia in the establishment of a state-of-the-art, well-equipped nuclear pharmacy and the establishment of a cross-organizational quality system.
Winning GPP certificate puts the Isotopia’s nuclear pharmacy and its quality system in line with the best nuclear pharmacies in Europe.
The quality unit includes pharmacists, quality assurance supervisors, and more. In addition, there is a well-equipped quality control laboratory, operated by a team of analytical chemists.