Laboratory Instrument Qualification
In the last couple of years USP <1058> became the global golden standard for analytical instrument qualification. The principle has also been applied for all laboratory equipment qualification and calibration. FDA and international inspectors refer to its qualification principles for GMP assessment of laboratory equipment . But still today companies struggle with implementation because <1058> does not really give specific advice on ‘how to’ qualify laboratory instruments.
VTI QC Validation Specialist understand laboratory instrument qualification better than anyone, because of our years of experience in this area. With our instrument qualification services, you can be confident that your instruments are installed, operating, and performing according to manufacturer’s specifications.
Our trained and experience QC Laboratory Validation Specialist will conduct comprehensive testing of your instruments using verified tests, certified tools, and developed standards to verify instrument performance. Reliable, audit-style documentation is provided to help you meet regulatory requirements and industry standards.
Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) or instrument performance verification (IPV) services verify and document your instrument’s ability to meet manufacturer design specifications for performance.
IQ—provides documented evidence and verification that the instrument has been delivered and installed according to manufacturer’s specifications
OQ—provides documented verification that the instrument subsystems are operating as designed. Verifies that the functionality of an instrument meets the manufacturer’s operational specifications.
PQ or IPV—provides documented verification that the instrument system can perform effectively and reproducibly within performance specifications. Helps ensure confidence in results by verifying that the accuracy and precision of an instrument is maintained.
Re-qualifications (OQ or OQ/PQ or OQ/IPV)—provide documented verification that the instrument continues to operate as specified by the manufacturer. Typically performed annually after an initial IQ, OQ, PQ, or IPV has been completed, or according to user’s SOP requirements.
* IQ: Instrument Qualification, OQ: Operational Qualification, PQ: Performance Qualification, IPV: Instrument Performance Verification.