Positron Emission Tomography Drug Inspections

ARTICLES

Quality System - PET

The review of the quality system is of major importance in the manufacture of PET drugs since the drugs are produced in low volumes and typically administered prior to the completion of sterility testing. Read More

Aseptic Sterility Control - PET

Inspection of the aseptic processing of the PET drug differs from that for a conventional large-scale aseptic production operation. The depth of aseptic processing coverage should be risk-based, which means focusing on the most critical process parameters and quality attributes. Read More

Facilities and Equipment System - PET

When this system is selected for coverage, investigators will cover all areas listed below; however, the depth of coverage may vary depending upon inspectional findings. Read More

Materials System - PET

This system includes measures and activities to control finished products, components, including water or gases that are incorporated into the product, containers and closures. Read More

Production System - PET

Production includes all operations to the point of final release of a finished dosage form. The use of a PET drug product after receipt by a receiving facility generally is regarded as the practice of medicine and pharmacy. [212 FR, p. 65411]. Read More

Packaging and Labeling System - PET

This system includes measures and activities that control the packaging and labeling of PET drugs and drug products. It includes label examination [212.80(b)], storage, handling, distribution and use, and controls to prevent labeling and product mix-ups. Read More

Laboratory Control System - PET

This system includes measures and activities related to laboratory procedures, sampling, testing, analytical methods development and verification and the stability program. Read More