HPLC & GC Qualification
The U.S. Food and Drug Administration (FDA) defines validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes”. The essential components of the validation process are Design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ), and a validated computer system.
Antech provide HPLC and GC Installation, Operational & Performance Qualification designed to meet your regulatory compliance challenges with confidence.
Our procedures are “Brand Neutral” to allow a harmonised validation standard across all laboratories & all departments irrespective of instrument manufacturer.
Our robust Standard Operating Procedures (SOP) and Protocols (previously audited at our customer sites by FDA & IMB), can be customised to suit the individual needs of your facility.
- IQ/OQ/PQ Certification
- HPLC Isocratic/Gradient Pumps, UV-Vis/PDA Detectors, Autosamplers, Chillers and Column Ovens
- GC Systems including all detector types
- Consultancy & Training
Fully supported HPLC and GC modules from Waters, Agilent, Shimadzu, Varian, Perkin Elmer, Thermo, Spectra Physics, Gilson……
Please click the Enquiry button to discuss your requirements.