Operational Qualification (OQ)
OQ Protocols in Pharma: Testing Performance & Compliance
OQ Protocols in Pharma: Testing Performance & Compliance Operational Qualification (OQ) in Pharma: How to Test Equipment Performance and Ensure Compliance Operational Qualification (OQ) is the documented verification that equipment, systems, or instruments operate as intended throughout all anticipated operating ranges. Following Installation Qualification (IQ), OQ is the second phase in the validation lifecycle and ensures that all critical functions and controls are tested under simulated or actual operating conditions. This comprehensive guide offers QA, QC, validation, and regulatory teams a structured, regulatory-compliant approach to OQ—covering protocol design, test execution, acceptance criteria, and audit-ready documentation aligned with FDA, EMA, and…