SOP for Equipment Qualification

1.0 PURPOSE

To lay down the procedure for equipment/machines and system qualification.

2.0 SCOPE

This procedure is applicable for all the equipment’s and machines, installation, Operation and Performance and to establish Standard at first place.

3.0 RESPONSIBILITY

Doing: User/Owner Department, Engineer and QA Executive
Review: Production, Engineering, Quality control
Approval: Quality Assurance

4.0 ACCOUNTABILITY

All Department Heads

5.0 PROCEDURE

Equipment/System qualification should include following :
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification

5.1. Design Qualification (DQ)

DQ defines the functional and operational specifications of the instrument and details the conscious decisions in the selection of the supplier. DQ should ensure that instruments/system has all the necessary functions and performance criteria that will enable them to be successfully implemented for the intended application and to meet business and regulatory requirements.
Design Qualification should include these steps :
5.1.1. Selection of the technique and/or type of equipment.
5.1.2. Description of the intended environment.
5.1.3. The description of how the instrument will be used in the selected environment and within a process. If the instrument will be used for several applications, describe a few typical scenarios.
5.1.4. Preliminary selection of the supplier.
5.1.5. Final selection of the equipment and qualification of the supplier and equipment.
5.1.6. Discussion and documentation of warranty, Familiarization, Training, Consulting and other vendor services.
5.1.7. Development and documentation of final functional and operational specifications.
5.1.8. Review and approval of user requirement and functional specifications by users of the system and by the Validation Team.

5.2. Installation Qualification (IQ)

Installation qualification establishes the documented evidence that the equipment is received as designed and specified that it is properly installed and configured in the selected environment and for the intended application.
Installation qualification should include the following steps:
5.2.1. Check if the environmental and safety conditions, e.g., power condition requirements, meet the criteria as specified for the instrument.
5.2.2. Compare equipment, as received, with the purchase order (including software, accessories, and spare parts).
5.2.3. Check the documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificate).
5.2.4. Check equipment for any damage.
5.2.5. Install hardware (computer, equipment, fittings and tubing for fluid connections, power cables, data flow and instrument control cables).
5.2.6. Switch on the instruments and ensure that all modules power up and perform an electronic self- test.
5.2.7. Install software on the computer following the manufacturer’s recommendation.
5.2.8. Verify correct software installation, e.g., verify that are all files loaded. Utilities to do this should be included in the software itself.
5.2.9. Make a backup copy of the software.
5.2.10. Configure peropherals, e.g. printers and equipment modules.
5.2.11. Identify and make a list with a description of all hardware, including drawings where appropriate.
5.2.12. Make a list of all software installed on the computer with description.
5.2.13. List equipment manuals and SOPs.
5.2.14. Develop Operation and calibration procedures.
5.2.15. Make entries into the equipment logbook.
5.2.16. Prepare an installation report.

5.3. Operational Qualification (OQ)

Operational qualification (OQ) is the process of demonstrating that an instrument will function according to its operational specification in the selected environment. The instrument should be tested against critical performance specifications as specified in the Design Specifications.
Follow the following steps while carrying out operational qualification:
5.3.1. Obtain functional and performance specifications (preferably use information from DQ).
5.3.2. Identify Critical functions that should be tested in the user environment.
5.3.3. Link the test cases to the user requirement and functional specifications as defined in DQ.
5.3.4. Develop SOPs for testing.
5.3.5. Test procedure should include what to test how testing should be conducted and the expected results with acceptance criteria.
5.3.6. Don’t use the manufacturer’s performance specification limits if the performance is expected to deteriorate over time. Take performance specification as required by the application.
5.3.7. Define the frequency of OQ as recommended by the vendor.
5.3.8. Define re-qualification criteria and procedures after equipment up-dates, moves and repairs.

5.4. Performance Qualification (PQ)

Performance qualification (PQ) is the process of demonstrating that an instrument consistently performs according to the specification appropriate for its routine use.
5.4.1. Define test procedures and the performance criteria for the complete system selecting critical parameters.
For example for Chromatographic System the performance parameters are:
The precision of the amount
The precision of retention time
Resolution between two peaks
Peak width at half height
Peak tailing
Limit of detection and limit of quantitation
Wavelength accuracy

5.4.2. Define the test intervals.

6.0 ABBREVIATIONS

6.1 EQ: Equipment/Machine Qualification Protocol
6.2 IQ: Installation Qualification
6.3 OQ: Operational Qualification
6.4 PQ: Performance Qualification

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