Standard Operating Procedure for Equipment Qualification (IQ/OQ/PQ)

1) Purpose

This SOP outlines the procedures for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment to ensure that equipment is properly installed, operates as intended, and consistently produces results meeting predefined specifications.

2) Scope

This SOP applies to all equipment used in the manufacturing, packaging, testing, and control of pharmaceutical products where equipment qualification is necessary to ensure compliance with regulatory requirements and maintain product quality.

3) Responsibilities

The Validation department or designated personnel are responsible for planning, executing, and documenting equipment qualification activities. Engineering, Production, and Quality Assurance (QA) departments are responsible for providing support and ensuring compliance with qualification protocols.

4) Procedure

4.1 Installation Qualification (IQ)

1. Verify and document that equipment is delivered and installed as per manufacturer specifications and installation drawings.
2. Check utilities (e.g., power, water, air) required for equipment operation.
3. Document equipment identification details and location.

4.2 Operational Qualification (OQ)

1. Verify and document that equipment functions as intended throughout its operational range.
2. Perform tests to ensure that all critical parameters are within specified limits.
3. Document test results and deviations, if any, and initiate corrective actions.

4.3 Performance Qualification (PQ)

1. Verify and document that equipment consistently produces results meeting predefined specifications.
2. Conduct tests under actual operating