Documentation & Validation (IQ, OQ & PQ)
Documentation and Validation, or IQ, OQ, and PQ, are sequential phases for qualifying equipment and processes, especially in regulated industries like pharmaceuticals. Installation Qualification (IQ) confirms correct installation, Operational Qualification (OQ) verifies proper function under expected conditions, and Performance Qualification (PQ) proves consistent performance during routine production. These steps provide documented evidence that a process or equipment reliably produces products of the required quality.
Installation Qualification (IQ)
Purpose: To ensure that the equipment or system is installed correctly, according to the manufacturer's specifications and design requirements.
Activities: Reviewing user manuals and specifications, verifying all components are present, checking the installation environment, and confirming proper connection of utilities like power and water.
Operational Qualification (OQ)
Purpose: To verify that the equipment or process operates as intended and meets performance specifications under controlled conditions.
Activities: Testing the equipment's functionality, determining process control limits, identifying failure modes, and setting action levels.
Performance Qualification (PQ)
Purpose: To provide documented evidence that the process consistently produces conforming products under actual, routine production conditions.
Activities: Running the process or equipment multiple times under normal operating conditions to confirm its reliability and stability over time.
Why IQ, OQ, and PQ Are Important
Ensures Product Quality: These steps establish documented proof that a process reliably produces products of the desired quality.
Regulatory Compliance: They are essential components of Good Manufacturing Practice (GMP) in highly regulated industries like pharmaceuticals, medical devices, and biotechnology.
Prevents Failures: By verifying equipment function and process stability, IQ, OQ, and PQ help prevent breakdowns, costly repairs, and potential patient harm.
Improves Efficiency: A well-validated system leads to more efficient operation, reduced downtime, and improved overall productivity.