Qualification Services

Objective

Qualification operations include analytical instrument qualification, process equipment qualification and commissioning & qualification for process facilities, premises and utilities. Qualification operations aim to verify that a process equipment or process facility is qualified and under control.

Definitions

Qualification verifies through documented activities that the process equipment, process facilities, analytical instruments, and devices, consistently operate according to specified specifications and quality standards.

Qualification activities ensure that process equipment and process facilities are properly designed, installed, and functions reliably to produce safe and reproducible products and satisfying regulatory GMP requirements throughout the product lifecycle.

Qualification process

The qualification process starts with the devise of the User Requirement Specifications (URS), which defines the laboratory’s technical and operational requirements, followed by the four qualification phases of DQ, IQ, OQ, and PQ, in which the URS should be part of the DQ.

Main qualification activities include risk assessment, system classification, testing activities along with vendor’s FAT and SAT and instrument calibration. A written qualification plan should specify how the qualification will be performed. The plan should be reviewed and approved by quality assurance (QA).