4/5 April 2023
The new WHO and IAEA guidelines are intended to provide a general overview of GMP (Good Manufacturing Practice) requirements for radiopharmaceuticals. While the basics of GMP are presented in the general chapters for pharmaceutical products (Good Manufacturing Practices for Pharmaceutical Products. In: WHO Expert Committee 520 on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World 521 Health Organization, 2014, Annex 2 (WHO Technical Report Series, No. 986) as well as for sterile pharmaceutical products (Quality Assurance of Pharmaceuticals. A Compendium of Guidelines and Related 524 Materials. Good Manufacturing Practices and Inspection. Geneva, World Health 525 Organization, 2018. ), this document deals with the particularities of radiopharmaceuticals. Unless otherwise stated, the GMP requirements for radiopharmaceuticals described in this guideline should take precedence over the GMP requirements for pharmaceuticals.
The regulatory procedures and processes required for the manufacture and control of radiopharmaceuticals are largely determined by the nature of these products, the manufacturing processes used and the intended use. Accordingly, this guideline is intended for the following scenarios:
In contrast, the following uses are not covered by the guide:
Currently, the draft is open for public consultation via the IAEA and the WHO mailing list as well as public web postings from January to March 2019. The rest of the process is planned as follows:
Further details can be found in the draft guidelines "International Atomic Energy Agency (IAEA)/WHO guidelines on good manufacturing products for radiopharmaceutical products (QAS/18.782)" on the WHO website in the section "Current Projects".