LAB-120 Qualification of Laboratory Instruments

5.1 General Qualification Requirements

5.1.1 When a new instrument is introduced into the laboratory, it must be assessed whether or not qualification is required. Not all instruments / equipment will require a qualification, such as a hotplate / stirrer or shaker. Only direct impact systems and equipment will be qualified, indirect and no impact systems and equipment will be commissioned only.

5.1.2 For an instrument that requires qualification, a qualification protocol number must be obtained from QC Laboratory Project Register Logbook..

5.1.3 A Site Change Control will be raised for the instrument to be qualified as per SOP QMS 125 Change Management System.

5.1.4 For an instrument with a computer control system, a user requirement specification will be written, followed by a qualification protocol. This protocol will include an Installation Qualification (IQ), an Operational Qualification (OQ) and a Performance Qualification (PQ). However, depending on the complexity of the instrument, IQ/OQ protocol can also be written and executed before and separate from the PQ protocol.

5.1.5 A summary report will be prepared upon completion of the qualification to indicate the qualification status.

5.2 Installation Qualification (IQ)

5.2.1 IQ documents that the instrument has been installed in accordance with site requirements, specifications and manufacturer’s recommendations. IQ can be performed in parallel with OQ.

5.2.2 The IQ documentation must include as a minimum:

5.2.2.1 A unique instrument ID number

5.2.2.2 Instrument description including serial numbers

5.2.2.3 Instrument location

5.2.2.4 Instrument supplier details

5.2.2.5 Instrument inspection certificates if any supplied

5.2.2.6 Signatures and date of colleague and/or vendor executing the IQ

5.2.2.7 Reference to procedure(s) for operation, calibration and maintenance.

5.2.3 The IQ must verify that:

5.2.3.1 The instrument is installed in accordance with site requirements, specifications and manufacturer’s recommendations

5.2.3.2 A risk assessment is performed to ensure that the instrument is safe to be used

5.2.3.3 Training has been performed and documented

5.3 Operational Qualification (OQ)

5.3.1 OQ documents that the instrument operates in accordance with site requirements, specifications and manufacturer’s recommendations.

5.3.2 The OQ documentation must include:

5.3.2.1 A unique instrument number

5.3.2.2 Instrument description

5.3.2.3 Instrument location

5.3.2.4 The qualification procedure

5.3.2.5 Qualification data

5.3.2.6 Signature and date of colleague and/or vendor executing the OQ

5.4 Performance Qualification (PQ)

5.4.1 PQ documents that an instrument can accurately quantify specified results using a specific quantitative analytical method on a consistent basis. Equipment performance qualification activities cannot begin until the IQ and OQ have been satisfactorily completed.

5.4.2 PQ documentation must include:

5.4.2.1 A unique instrument number 5.4.2.2 Instrument description

5.4.2.3 Signature and date of colleague executing PQ

5.4.2.4 Procedures to ensure and verify that the entire system is performing satisfactorily.

5.5 Qualification of Existing Equipment

5.5.1 Retrospective qualification can be performed on established equipment. It does not require as detailed IQ, OQ or PQ as new equipment. Routine calibration data can be used to support and verify the performance of equipment.

5.5.2 For existing HPLC systems, firmware update for any module should have a Site Change Control raised for the instrument to be qualified as per SOP QMS 125 Change Management System, and a qualification protocol (qualification protocol number obtained from the logbook) written detailing the IQ/OQ/PQ procedure to be performed.

5.6 Post Service Qualification for Instrumentation

5.6.1 HPLC Systems

5.6.1.1 When HPLC systems are repaired / serviced, it must be assessed as to whether the repair is considered major or minor (refer to Table 1).

5.6.1.2 When a major repair / service / replacement takes place, PQ on the entire system needs to be carried out according to the procedures detailed in SOP LAB-090 HPLC Reproducibility, Column Performance and Testing Guidelines.

5.6.1.3 When a minor repair takes place, calibration of the module / component that was repaired or replaced will be assessed and performed accordingly.

Note: Cleaning or replacement of check valves is not considered to be either a major or minor repair and no qualification of the instrument is required.

 Table 1: Guidelines for Major and Minor Repairs of HPLC Systems

5.6.2 Other Instruments

When an instrument (besides HPLC systems) is repaired / serviced or relocated, it must be assessed by the QC Laboratory Manager or Designee as to whether a qualification or calibration is required.

5.7 Qualification Report

A qualification report is to be prepared by the Laboratory Project Chemist to summarise the result of the execution of IQ/OQ and PQ after a qualification has been performed.