Sample Work

A selection of GxP documentation produced for portfolio purposes. Redacted samples will be available to view and download here.

Documents

STO-SOP-RCP-001

Radiochemical Purity Testing

A GxP SOP for determining the radiochemical purity of radiopharmaceutical drug products using HPLC-RAD and radio-TLC. Written to USP, Ph. Eur., and 21 CFR Parts 211 and 212.

Sample coming soon

STO-SOP-DEV-001

Laboratory Deviation & Investigation

A GxP SOP covering deviation identification, documentation, root cause investigation, and CAPA management in analytical operations.

Coming soon

STO-SOP-PRM-001

Primary Reference Material

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

Coming soon