Analytical Instrument Qualification (AIQ) in a QC laboratory is a structured quality assurance process governed by standards like USP <1058> and cGMP. It ensures that every piece of lab equipment performs consistently, accurately, and produces reliable data.
Design Qualification (DQ): Outlines the requirements before buying the equipment.Creating a User Requirements Specification (URS) detailing required technical parameters (accuracy, resolution, software features).Evaluating vendor compliance, support, and ISO/GMP certifications.
Installation Qualification (IQ): Confirms the instrument is installed properly in the lab environment.Checking workspace conditions (power supply, ambient temperature, humidity, and airflow).Verifying delivered parts, model numbers, serial numbers, manuals, and accessories against the purchase order.
Operational Qualification (OQ): Verifies the instrument operates correctly within its specified ranges.Testing core operational functions (temperature controls, flow rates, detector response, alarm checks).Testing software compliance, user permissions, audit trails, and data security controls (e.g., 21 CFR Part 11).
Performance Qualification (PQ): Ensures consistent performance during actual routine testing.Conducting System Suitability Tests (SST) using standard reference materials.Verifying precision, repeatability, and accuracy using real sample matrices.
