Standard operating procedure for Equipment Qualification is a critical process in various industries, including pharmaceuticals, biotechnology, healthcare, and manufacturing. It ensures that equipment meets specified requirements and is suitable for its intended purpose. Standard Operating Procedures (SOPs) for equipment qualification help maintain consistency, reliability, and compliance with regulatory standards.

Objective:

Objective of this SOP is to address the guidelines for the execution of the Equipment Qualification i.e. (Installation Qualification (IQ)), (Operational Qualification (OQ)) and (Performance Qualification (PQ)). Clearly state the purpose of the SOP, which is to define the systematic process for qualifying equipment to ensure its reliability, accuracy, and compliance with regulatory standards.

Scope:

This SOP covers guidelines for all the Analytical Equipment Qualifications including IQ, OQ and PQs. Specify the scope of the SOP, including the types of equipment covered, departments involved, and the stages of qualification (e.g., Installation Qualification, Operational Qualification, Performance Qualification).

Responsibility:

Clearly outline the responsibilities of individuals and departments involved in the equipment qualification process, including roles such as the Equipment Owner, Qualification Team, and Quality Assurance.

Procedure:

I- Installation Qualification:

Definition Standard operating procedure for Equipment Qualification:

Installation Qualifications is the activity which includes all the systematic steps from receiving and unpacking to the complete hardware and software installation of equipment.

Following steps are followed during the execution of Installation Qualification (IQ)

1. Installation Qualification Protocol – Before going to execute the Qualification, “Installation Qualification Protocol” is prepared got reviewed and approved from the relevant personnel.
2. Standard operating procedure for Equipment Qualification

Execution of the qualification includes the following steps:

1. Approval Page – Approvals from all the relevant personnel like Prepared By, Reviewed By and Approved By.
2. Objective – Standard operating procedure for Equipment Qualification
3. Scope – Standard operating procedure for Equipment Qualification
4. User Requirements – all the requirements are mentioned before going to purchase the equipment i.e. Brand, Specifications, Range and Power Supply required etc.
5. Equipment Description – includes Equipment Name, Model, Manufacturer, Vender and detailed description of the equipment, Utilities and Software required.
6. Qualification Test Procedure – includes all test procedure and acceptance criteria.
7. Verification of critical test data sheet – includes all the tests performed and their results with the acceptance criteria.

Appendices

Includes the following appendices

Standard operating procedure for Equipment Qualification

Qualification Notes

(b) Qualification Test equipment calibration certificates
(c) Deviations
(d) Documentation Inventory Table

Following steps are followed during the execution of Operational Qualification (OQ)

Operational Qualification Protocol – Before going to execute the Qualification, “Operational Qualification Protocol” is prepared got reviewed and approved from the relevant personnel.

Execution of the qualification includes the following steps:

1. Approval Page – Approvals from all the relevant personnel like Prepared By, Reviewed By and Approved By.
2. Signature Identification Page
3. Objective
4. Scope
5. User Requirements – all the requirements are mentioned before going to purchase the equipment i.e. Brand, Specifications, Range and Power Supply required etc
6. Equipment Description – includes Equipment Name, Model, Manufacturer, Vender and detailed description of the equipment, Utilities and Software required
7. Qualification Test Procedure – includes all test procedure and acceptance criteria
8. Verification of critical test data sheet – includes all the tests performed and their results with the acceptance criteria
9. Appendices

Includes the following appendices

(a) Qualification Notes
(b) Qualification Test equipment calibration certificates
(c) Deviations
(d) Test Data Documentation

Performance Qualification:

Definition:

Performance Qualifications is the activity which includes all the systematic steps performed on the equipments during the Real Time Analysis of the products.

Following steps are followed during the execution of Performance Qualification (PQ)

Performance Qualification Protocol–Before going to execute the Qualification, “Performance Qualification Protocol” is prepared got reviewed and approved from the relevant personnel.

Execution of the qualification includes the following steps:

1. Approval Page – Approvals from all the relevant personnel like Prepared By, Reviewed By and Approved By.
2. Signature Identification Page
3. Objective
4. Scope
5. User Requirements – all the requirements are mentioned before going to purchase the equipment i.e. Brand, Specifications, Range and Power Supply required etc
6. Equipment Description – includes Equipment Name, Model, Manufacturer, Vender and detailed description of the equipment, Utilities and Software required
7. Qualification Test Procedure – includes all test procedure and acceptance criteria
8. Verification of critical test data sheet – includes all the tests performed and their results with the acceptance criteria
9. Appendices

Includes the following appendices

(a) Qualification Notes
(b) Qualification Test equipment calibration certificates
(c) Deviations

Test Data Documentation Inventory Table.

Revision History: First issued