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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
December 31, 2024

Writing Effective SOPs in Pharmaceuticals

1. Introduction Standard Operating Procedure (SOP) as used in the pharmaceutical industry is an important document that is designed to provide details of a specific process or operation and dictates proper means to perform that operation. Lastly, SOPs are very useful and also when it comes to compliance with set regulations, but SOPs give directives to employees to adhere to […]

0 3 min read