GMP for Radiopharmaceuticals - WHO/IAEA Guideline open for comments

This summer, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) published a draft GMP guideline for radiopharmaceutical products for public comment. This document is intended to give users and manufacturers a general overview of the minimum requirements for Good Manufacturing Practices (GMP) for radiopharmaceuticals.

The general principles of good manufacturing practice are already described in the WHO's general guidelines on GMP:

  • Good Manufacturing Practices for Pharmaceutical Products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 2014, Annex 2 (WHO Technical Report Series, No. 986).
  • Quality Assurance of Pharmaceuticals. A Compendium of Guidelines and Related Materials. Good Manufacturing Practices and Inspection. Geneva, World Health Organization, 2018.
  • Good Manufacturing Practices for Sterile Pharmaceutical Products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-sixth report. Geneva, World Health Organization, 2011, Annex 6 (WHO Technical Report Series, No. 961).

However, for the specific case of radiopharmaceuticals, the future paper should take priority over the GMP requirements for pharmaceuticals - unless it is otherwise described. Since the manufacture, monitoring and quality control of radiopharmaceutical products are largely determined by their special properties and intended use, the WHO and IAEA provide  the application of this guideline for the following scenarios:

  • The manufacture or compounding of radiopharmaceuticals in hospital radiopharmaceuticals, including diagnostic and therapeutic products.
  • The manufacture or compounding of radiopharmaceuticals in centralised radiopharmacies.
  • The manufacture or compounding of radiopharmaceuticals in nuclear centres and institutes..
  • The manufacture of radiopharmaceuticals by industrial manufacturers.
  • The manufacture of cyclotron-based positron emission tomography (PET) radiopharmaceuticals.

According to the authors, however, the following products, applications and processes are not covered by this directive:

  • Radiopharmaceutical dispensing (i.e. the drawing of a patient specific unit dose from a bulk vial of a radiopharmaceutical).
  • Regulatory approved radiopharmaceutical preparation (i.e. the use of approved kits and approved generators to manufacture a radiopharmaceutical product according to the instructions of the marketing authorisation holder).
  • Handling of ready-to-administer radiopharmaceutical products (e.g. reception, storage, assay, etc.).
    Production or compounding of non-radioactive compounds, including cold kits.
  • Manufacture of radiopharmaceutical investigational medicinal products.

Further details can be found in the draft guideline IAEA/WHO Guidelines on GMP for Radiopharmaceutical Products. It is open for comment until 20 September.

Please note in this context the new course of the ECA Academy "GMP and Quality for Radiopharmaceuticals".

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