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Manufacture of sterile radiopharmaceuticals labelled with fluorine-18

Interpretation of the PIC/S guide to GMP

11 February 2019

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Manufacturing formula and processing instructions

Approved manufacturing formula and processing instructions in writing are required for each product to be manufactured. The basic requirements of Chapter 4 of the PIC/S Guide to GMP still apply, although it is common for these to be included in one concise document.

Include all items used in the manufacture of the product in the Bill of Materials (BOM) with their uniquely identifiable batch number. Where a separate BOM is not used, list these items on the batch record.

A statement of the expected final yield with the acceptable limits, and yields for relevant intermediates, where applicable, should be included in the manufacturing formula (part I, clause 4.17d).

Retention of documentation

Retain all records associated with the manufacture of sterile radiopharmaceuticals labelled with fluorine-18 for at least 3 years (Annex 3.33).

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