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)
- Verify and document that equipment is delivered and installed as per manufacturer specifications and installation drawings.
- Check utilities (e.g., power, water, air) required for equipment operation.
- Document equipment identification details and location.
4.2 Operational Qualification (OQ)
- Verify and document that equipment functions as intended throughout its operational range.
- Perform tests to ensure that all critical parameters are within specified limits.
- Document test results and deviations, if any, and initiate corrective actions.
4.3 Performance Qualification (PQ)
- Verify and document that equipment consistently produces results meeting predefined specifications.
- Conduct tests under actual operating conditions using production materials or simulated product.
- Document test results, evaluate performance against acceptance criteria, and obtain approval.
4.4 Requalification and Maintenance
- Establish requalification schedules based on equipment criticality and regulatory requirements.
- Perform periodic requalification and maintenance activities to ensure continued equipment performance and compliance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
QA: Quality Assurance
6) Documents, if any
Installation Qualification Protocol, Operational Qualification Protocol, Performance Qualification Protocol, Requalification Protocol
7) Reference, if any
Regulatory guidelines such as FDA Process Validation Guidance, EMA guidelines, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
8) SOP Version
Version 1.0
