WHO and IAEA - Draft Guideline on GMP for Radiopharmaceuticals

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6/7 February 2024

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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:

• The manufacture of radiopharmaceuticals in hospital radiopharmaceuticals, including diagnostic and therapeutic products. 
• The production of radiopharmaceuticals in central radiopharmaceutical companies.
• Production of radiopharmaceuticals in core centres and institutes.
• The production of radiopharmaceuticals by industrial manufacturers.
• The production of cyclotron-based positron emissions.

In contrast, the following uses are not covered by the guide:

• Authorised radiopharmaceutical preparation and dispensing. (e.g. receipt, handling, storage and use of kits, generators and ready-to-use doses; taking a patient-specific single dose from a sample vessel of a radiopharmaceutical). In such cases, the instructions of the marketing authorisation holder must be followed.
• Own manufacture or compounding of non-radioactive compounds, including cold kits. 
•  Internal preparation of radiopharmaceutical investigational medicinal products

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:

• Review of the comments received in a common format until April 2019.
• Review of the document on the basis of the data and comments received
• Further public consultation and public consultation, review the opinions of IAEA specialists and staff and communicate the final results to WHO.
• Presentation at the IAEA International Symposium on Trends in Radiopharmaceuticals (ISTR -2019) at the IAEA Headquarters in Vienna, Austria, 28 October to 1 November 2019.
• Presentation of the results to the 54th WHO Expert Committee on Specifications for Pharmaceutical Preparations 14-18 October 2019

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".