GMP for Radiopharmaceuticals - existing and expected Guidelines

In August 2013, the PIC/S published their annual report 2012. Amongst other topics, they informed in section 38 that the Working Group on Annex 3 to PE 010 to the PIC/S Guide to Good Practices for the Preparation of Radiopharmaceuticals in Healthcare Establishments (PE 010) held its 3rd meeting in London on 25-26 October 2012. A first draft of Annex 3 was submitted for comments to PIC/S Participating Authorities in December 2012.

Currently the new Annex 3 to PE 010-3 is in the final stages for adoption by the PIC/S Committee. It will be integrated into PE 010-3 and hopefully published in January 2014. So far, the PIC/s has only a few recommendations about quality and safety in their General Guide to Good Practices for the preparation of Medicinal Products in Healthcare establishments (PE 010-3). Other documents like the World Health Organization (WHO) Technical Report Series, No. 908, 2003, Annex 3 "Guidelines on Good Manufacturing Practices for radiopharmaceutical products" are much older. The EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 3 Manufacture of Radiopharmaceuticals is one of the newest international guidance documents. The last revised version came into operation on 1 March 2009.

To stay informed about the current developments and requirements on quality and safety of radiopharmaceuticals, please pay attention to ECAs new event "Radiopharmaceuticals - Quality, Safety and GMP Requirements" on 5 and 6 February 2014 in Vienna Austria. Speakers from Authorities, IAEA, Industry and healthcare establishments will present the regulatory background, inspection experiences and possibilities for implementation of quality requirements in the establishments.

Go back

x