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February 15, 2025

Performing Operational Qualification: A Step-by-Step Guide

Operational Qualification (OQ) is a critical component of equipment and system validation in regulated industries, particularly in pharmaceuticals. It provides documented evidence that the equipment or system operates consistently within its specified parameters and meets pre-defined acceptance criteria. A well-executed OQ ensures that the equipment functions as intended, contributing to product quality, safety, and regulatory compliance. This article provides a […]

0 5 min read
February 15, 2025

Operational Qualification (OQ) vs. Performance Qualification (PQ) in Validation

In regulated industries like pharmaceuticals, medical devices, and biotechnology, validation is paramount. It’s the documented proof that a process, system, or piece of equipment consistently produces results meeting predetermined specifications and quality attributes. Within the broader validation lifecycle, two critical stages often cause confusion: Operational Qualification (OQ) and Performance Qualification (PQ). While both are essential for ensuring quality and compliance, […]

0 5 min read