GMP for Radiopharmaceuticals - existing and expected Guidelines

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

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.