Radioactive Drugs Inspections

ARTICLES

Radiologiocal Safety - Radioactive

FDA investigator teams assigned to inspections of radioactive drug manufacturers are expected to be familiar with radiation detection equipment and safety precautions. Read More

Raw Materials - Radioactive

FDA investigators must determine the adequacy of each company’s control procedures for handling raw materials and components. Read More

Manufacturing Controls - Radioactive

FDA investigators must report steps taken by the company to prevent the absorption of radionuclides on the walls of containers and preparation vessels. Document the use of any coating materials and the company’s validation that absorption does not occur and that delivery of the full dose is assured. Read More

Generator Systems - Radioactive

The use of nuclide generators, such as the Mo 99m/Tt 99m generator, has increased in recent years and they pose special problems. Read More

Packaging and Labeling - Radioactive

FDA investigators must among other things report procedures for storing, issuing and accounting for labeling and insert materials. Give particular attention to small custom batches. Read More

Analytical Controls - Radioactive

FDA investigators must report any microbiological, chemical, and pyrogen tests performed on water intended for parenteral preparations. Plus more ... Read More

Complaints - Radioactive

FDA investigators must check complaint files for drug defects, drug administration problems, adverse experience reports and product rejections. Read More

Sampling - Radioactive

FDA investigators should identify products from the company’s price list or catalog that should receive analytical coverage based on inspectional findings, recalls, complaints, etc. Read More