Radiopharmaceutical preparations must comply with labelling requirements set by GMP guidelines. The following information are critical and should be observed during preparation of labels for the primary container:
- Statement that the product is radioactive OR should have the international symbol for radioactivity.
- Name of the radiopharmaceutical preparation.
- Application of the preparation: diagnostic or therapeutic use.
- Route of administration.
- Total activity present at a stated date and *time:
- Solutions: statement of radioactivity in a suitable time (MBq/ml) may be given.
- Expiry date and *time.
- Batch or lot number as per the manufacturer.
- Total volume of preparations in solution.
*Note: input information on time as applicable.
As for the preparation of secondary container labels, observe the following:
- Statement that the product is radioactive OR should have the international symbol for radioactivity.
- Name of the radiopharmaceutical preparation.
- Application of the preparation: diagnostic or therapeutic use.
- Route of administration.
- Total activity present at a stated date and *time:
- Solutions: statement of radioactivity in a suitable time (MBq/ml) may be given.
- Expiry date and *time.
- Batch or lot number as per the manufacturer.
- Total volume of preparations in solution.
- Any special storage requirements.
- Name and concentration of any added antimicrobial preservatives, if any. If none, then information that no antimicrobial preservative is in the preparation should be present.
*Note: input information on time as applicable.
References:
- https://www.who.int/medicines/publications/pharmacopoeia/Radgenmono.pdf
