IQ, OQ and PQ Qualification for HPLC and GC
Installation, operational and performance qualification (IQ, OQ, PQ) for HPLC and GC systems, with documents ready for pharma audits.
Key facts
- Based in
- Ambernath, Thane, Maharashtra · since 2022
- Instruments
- HPLC, GC, LC-MS and UV-Vis
- Brands
- Shimadzu, Waters, Agilent Technologies, Thermo Scientific, Merck, PerkinElmer
- Services
- Installation · Preventive Maintenance · Breakdown Service · AMC · CMC · Calibration · IQ · OQ · PQ · Validation · Software Installation · Training
- Reach us
- +91 9819424897 (phone) · +91 9819424897 (WhatsApp) · visionanalytical96@gmail.com · customer support info@visionanalytical.co.in
Monday to Saturday, 9:00 am to 6:30 pm IST, closed on Sunday
Three stages, three questions
Installation Qualification (IQ) answers whether the instrument was received as ordered and installed to the manufacturer's specification, with utilities such as power, gas and drainage checked. Operational Qualification (OQ) answers whether it performs to specification, by testing parameters such as flow rate accuracy, wavelength accuracy, column oven temperature and injection precision against calibrated reference standards. Performance Qualification (PQ) answers whether it performs reliably under your own operating conditions and is usually repeated on a schedule, for example once a year. Auditors ask for all three because together they form a documented chain of evidence from correct installation to trustworthy daily results.
Model-specific protocols, not a generic form
Our protocols are written for the instrument model in front of the engineer. The tests, acceptance limits and data tables follow the module configuration, for example a Waters Alliance e2695 separations module with a 2489 UV/Visible detector, or a Shimadzu LC-2010 integrated HPLC. Each document records the reference standards and their traceability, the measured values, the acceptance criteria and the result. The engineer performs the tests and records the data; the laboratory's QC reviews the record and its QA approves it, so the document fits your own quality system.
When qualification is needed
Plan IQ and OQ when a new or refurbished instrument is installed, when an instrument is relocated to another laboratory or site, and after a major repair such as a pump or detector replacement. PQ is scheduled through the year, often alongside preventive maintenance so the system is serviced first and then qualified. We qualify HPLC, GC and UV-Vis systems from Waters, Shimadzu, Agilent Technologies, PerkinElmer and Thermo Scientific for pharmaceutical, contract testing and research laboratories across Maharashtra and Gujarat.
What to send us
Send the make, model and serial number of each module, the software and its version, the reason for qualification (new installation, relocation, repair or the annual schedule) and any protocol format your QA already requires. If your QA has its own template we can work to it; if not, we provide ours.
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What is the difference between IQ, OQ and PQ for an HPLC?
IQ confirms the HPLC was delivered as ordered and installed correctly. OQ tests that it performs to specification, for example flow rate accuracy, wavelength accuracy, oven temperature and injection precision, using calibrated standards. PQ confirms it performs reliably with your own methods and conditions and is usually repeated on a schedule, such as once a year.
When does an HPLC need requalification?
An HPLC needs IQ and OQ again after it is moved to another laboratory or site and after a major repair such as a pump, injector or detector replacement. PQ is repeated on the schedule your quality system sets, commonly once a year and often straight after a preventive maintenance visit so the system is qualified in serviced condition.