AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data.

PHASES OF QUALIFICATION

  1. DESIGN QUALIFICATION (DQ):- It define the functional and operational specifications of an instrument and criteria for selection of vendor. It is an documented evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of good manufacturing practices.
  • It must be performed by manufacturer and user also.
  • Manufacturer responsible for robust design, info. Regarding manufacturing and testing.
  • User determine manufacturing capability for support installation, service and testing.
  1. INSTALLATION QUALIFICATION (IQ):- It is define as the performance of tests to ensure that the installations (such as machines, measuring devices, utilities and manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.
  • Description:- manufacturer, model, serial no., software version, location.
  • Instrument delivery:- During delivery it must be ensure that all the related accessory must be
  • Utility/ environment:- Site must meet manufacturer specified environments requirements.
  • Assembly and installation:- It must be done by vendor, engineer and must be tested.
  • Installation verification:- After installation perform initial diagnostic and testing.
  1. OPERATIONAL QUALIFICATION (OQ):- It defines that instrument will function according to OQ in selected environment. It is a documented verification that the system or subsystem performs as intended over all anticipated operating ranges.
  • Fixed parameters:- height, length, weight, voltage input, load and pressure should be checked.
  • Instrument function test:- User test to verify instrument operation as intended by vendor.
  1. PERFORMANCE QUALIFICATION (PQ):- It must be performed to ensure that instrument consistently perform according to specification. It is a documented verification that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged period.
  • Performance check:- Setup a series of test to verify performance of instrument. Repeat the PQ test each time so that a history of instrument performance can be compiled.
  • Preventive maintenance and repair:– if PQ of an instrument fails than PM/ repair must be
  • Calibration, change control:- It must be done time to time to ensure consistent performance of an instrument.                                                                                             FIND MORE AT…

         Reference links:-

http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidelines_validation_qualification_systems-utilities-equipment_QAS16-673.pdf?ua=1

http://www.wellspringcmo.com/blog/what-are-iq-oq-and-pq-and-why-are-they-required-in-pharmaceutical-industry

https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1058.pdf