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February 19, 2025

Standard Operating Procedure For Revalidation Procedure

Purpose: This document outlines the procedure for revalidating equipment, processes, and systems to ensure continued compliance with established standards and regulatory requirements. 1. Revalidation Categories 1.1. Process Revalidation: Generally, process revalidation (excluding sterile/aseptic processes) is not routinely performed. Validated status is maintained through the change control system. Revalidation outside of change control is considered only if there are repeated or […]

0 3 min read
February 18, 2025

Installation Qualification: A Cornerstone of Quality in Regulated Industries

In the highly regulated world of pharmaceuticals, biotechnology, medical devices, and other similar industries, ensuring the quality, safety, and efficacy of products is paramount. This necessitates rigorous processes for the design, installation, and operation of equipment used in manufacturing and research. Among these processes, installation qualification (IQ) stands as a critical first step. This article delves into the intricacies of […]

0 4 min read
February 18, 2025

How to Complete Installation Qualification: A Step-by-Step Guide

Installation qualification (IQ) is a crucial process in regulated industries like pharmaceuticals, biotechnology, and medical devices. It provides documented evidence that equipment has been installed correctly and in accordance with design specifications and manufacturer recommendations. A well-executed IQ is essential for ensuring product quality, safety, and regulatory compliance. This article provides a detailed, step-by-step guide on how to complete installation […]

0 4 min read
February 18, 2025

Drafting a Robust Installation Qualification Protocol

Installation Qualification (IQ) is a cornerstone of quality assurance in regulated industries like pharmaceuticals, biotechnology, and medical devices. It provides documented evidence that equipment has been installed correctly and in accordance with design specifications and manufacturer recommendations. A well-structured IQ protocol is essential for a successful qualification process. This article outlines the essential components of a robust IQ protocol, incorporating […]

0 4 min read
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