Who can qualify one HPLC, GC or LC-MS (IQ/OQ/PQ)?

Instrument qualification shows the system is installed correctly (IQ), operates to specification (OQ) and performs for its intended use (PQ). USP <1058> frames analytical instrument qualification in a risk-based way. Manufacturers and independent service providers both offer it.

What the method covers

HPLC/UHPLC, GC, LC-MS and GC-MS systems, including software and data system configuration.

Applicability caveats

• Vendor protocols may not cover third-party modules — list every module.
• Computerized system validation of the data system is related but separate work.
• PQ often relies on your methods and acceptance criteria.

Request this test · Equipment qualification & validation consulting