Current Good Manufacturing Practice with integrated Building Management System in the production of PET Radiopharmaceuticals

Janevik-Ivanovska, Emilija (2018) Current Good Manufacturing Practice with integrated Building Management System in the production of PET Radiopharmaceuticals. In: 7th Balkan Congress of Nuclear Medicine, 9-12 May 2018, Sarajevo, BiH.

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Abstract

Radiopharmaceutical production process must adhere to the current Good Manufacturing Process (CGMP) to ensure the quality of precursor, prodrug (active pharmaceutical ingredient, API), and the final drug product that meet acceptance criteria. We aimed to develop and introduce an automated and integrated Building Management System in the production of PET Radiopharmaceuticals of CGMP grade of PET radiopharmaceuticals. The System was completely validated (IQ, OQ, PQ) before be introduced in the routine work. The experience after more than one year showed a big advantage in comparison of separately used systems.

Item Type: Conference or Workshop Item (Lecture)
Subjects: Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Emilija Janevik
Date Deposited: 06 Feb 2019 08:06
Last Modified: 06 Feb 2019 08:06
URI: http://eprints.ugd.edu.mk/id/eprint/21490

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