The GMP (Good Manufacturing Practice Standard) is a set of rules that establish the requirements for organizing the production of medicines. GMP rules contain the actual requirements of good manufacturing practice, including requirements for the system of production support, personnel work, quality control, premises, equipment and documentation.
The process of preparing the production site for GMP certification was long and labor-intensive, as it required strict compliance with all relevant safety, energy efficiency, and environmental requirements.
The production site of the cyclotron-production complex of the Nuclear Medicine Center of Medical Center Hospital of the President’s Affairs Administration of the Republic of Kazakhstan will produce radiopharmaceuticals, and therefore special importance is given to compliance with radiation safety requirements.
After completion of qualification and validation activities, as well as the preparation of all internal documents, a self-inspection (internal audit) was carried out, following which an application for an external inspection of confirmation of GMP requirements under the EEC requirements was submitted.
As a result, on May 25, according to the results of external inspection by the Committee of pharmaceutical and medical control of the Ministry of Health of the Republic of Kazakhstan and the decision of the Committee of pharmaceutical and medical control of the Ministry of Health of Kazakhstan GMP certificate was issued for operation of the production site of cyclotron-production complex of the Nuclear Medicine Center.
