Governing GxP SOP for radiochemical purity determination of radiopharmaceutical drug products using HPLC-RAD and radio-TLC analytical techniques. Written to USP, Ph. Eur., and 21 CFR Part 211/212 standards.

Governing GxP SOP for deviation identification, documentation, root cause investigation, and CAPA management across analytical operations.

Governing GxP SOP for receipt, qualification, storage, and use of primary reference standards in GxP analytical environments.