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 here >>  to discuss your requirements. 

Antech provide a full range of services for our handheld range of spectrometers (NIR and Raman) including Installation, Operational & Performance Qualification, SOP creation and support, designed to meet your specific needs with confidence.

Our robust Standard Operating Procedures (SOP) and Protocols (previously audited at our customer sites by FDA, MHRA & HPRA), can be customised to suit the individual needs of your facility.

• IQ/OQ/PQ Certification
• Recertificaton
• SOP writing and support
• Consultancy & Training
• Ranges of Support Contracts

Please click here >>  to discuss your requirements.

Tablet Dissolution and Disintegration Qualification Services

Erweka • Vankel • Sotax • Distek • Pharmatest • Caleva • Hanson

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.

Our procedures are “Brand Neutral” to allow a harmonised validation standard across all laboratories & all departments irrespective of instrument manufacturer.

 Please click here >>  to discuss your requirements.