WHO TRS (Technical Report Series) 1025, 2020 Annex 2


WHO TRS (Technical Report Series) 1025, 2020 Annex 2

International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products

1. Scope:

This guideline provides a general overview of the minimum good manufacturing practices (GMP) requirements for radiopharmaceutical products. The main principles of GMP are described in detail in the WHO guidelines related to pharmaceutical products (1, 2), as well as in those for sterile pharmaceutical products (3).

The procedures necessary to manufacture, prepare and control radiopharmaceutical products are in large part determined by the nature of these products, the methods of manufacture and their intended use. The recommendations in this guideline are applicable to:

■ the production, preparation or compounding of radiopharmaceuticals in hospital radiopharmacies, including diagnostic and therapeutic products;

■ the production or compounding of radiopharmaceuticals in centralized radiopharmacies;

■ the production or compounding of radiopharmaceuticals in nuclear centres and institutes;

■ the production of radiopharmaceuticals by industrial manufacturers; and

■ the production of cyclotron-based radiopharmaceuticals.

The scope of this guidance does not include:

■ radiopharmaceutical dispensing (i.e. the drawing of a patient’s specific unit dose from a bulk vial of a radiopharmaceutical product);

■ regulatory authority-approved radiopharmaceutical preparation (i.e. the use of approved kits and approved generators in order to produce a radiopharmaceutical product as per instructions of the marketing authorization holder);

■ handling of ready-to-administer radiopharmaceutical products (e.g. receipt, storage, assay, etc.);

■ production or compounding of non-radioactive compounds, including cold kits; or

■ production of investigational radiopharmaceutical products.

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WHO TRS (Technical Report Series) 1025, 2020 Annex 2:

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