SOP For equipment qualification is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

To lay down the procedure for equipment qualification.

SCOPE

This procedure is applicable for all the equipment’s installation, Operation and Performance qualifications.

RESPONSIBILITY

QA Officer

Production Pharmacist 

QC Analyst

ACCOUNTABILITY

Manager Quality Assurance

Manager Quality Control

Manager Production

PROCEDURE

Qualification process of equipment's include following :

  • Design Qualification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification

Design Qualification (DQ)

DQ defines the details and the conscious decisions in the selection of the supplier. 

DQ should ensure that equipment has all the necessary functions and performance criteria  to meet regulatory requirements.

DQ should include these steps:

Selection of the type of equipment.

Description of the intended environment.

The description of how the instrument will be used in the selected environment and within a process. 

Preliminary selection of the supplier.

Final selection of the equipment and qualification of the supplier and equipment.

Discussion and documentation of warranty, Training, Consulting and other vendor services.

Review and approval of user requirement and functional specifications by users of the system and by the Validation Team.

Installation Qualification (IQ)

Installation qualification establishes the documented evidence that the equipment is received as designed and specified that it is properly installed.

Installation qualification should include the following steps:

Check if the environmental and safety conditions, e.g., power condition requirements, meet the criteria as specified for the instrument.

Compare equipment, as received, with the purchase order (including software, accessories, and spare parts).

Check the documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificate).

Check equipment for any damage.

Install hardware (computer, equipment, fittings and tubing for fluid connections, power cables, data flow and instrument control cables).

Switch on the instruments and ensure that all modules power up and perform an electronic self- test.

Install software on the computer following the manufacturer’s recommendation.

Verify correct software installation, e.g., verify that are all files loaded. Utilities to do this should be included in the software itself.

Make a backup copy of the software.

Identify and make a list with a description of all hardware, including drawings where appropriate.

Make a list of all software installed on the computer with description.

List equipment manuals and SOPs.

Develop Operation and calibration procedures.

Make entries into the equipment logbook.

Prepare an installation report.

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:

Identify Critical functions that should be tested in the user environment.

Link the test cases to the user requirement and functional specifications as defined in DQ.

Develop SOPs for testing.

Test procedure should include what to test how testing should be conducted and the expected results with acceptance criteria.

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.

Define the frequency of OQ as recommended by the vendor.

Define re-qualification criteria and procedures after equipment up-dates, moves and repairs.

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.

Define test procedures and the performance criteria for the complete system selecting critical parameters.