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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
January 26, 2025

Calibration, Validation, and Qualification Differences in the Pharmaceutical Industry

The pharmaceutical industry operates under stringent regulatory requirements to ensure product safety, efficacy, and quality. Core concepts like calibration, validation, and qualification are vital for maintaining compliance, meeting Good Manufacturing Practices (GMP), and ensuring the consistency of manufacturing processes. These three processes, though interconnected, have distinct purposes and applications in pharmaceutical operations. Understanding their differences and the roles they play […]

0 5 min read
December 31, 2024

Revalidation of pharmaceutical processes

Introduction The pharmaceutical line of business has evolved significantly since it was started Trading. Due to enhancing need for quality and safety of drugs, frequent evaluating of the processes used in the production of these drugs has become a critical issue. Practical approach to achieve this objective as highlighted involves revalidation of pharmaceutical process. In the pharmaceutical context revalidation can […]

0 4 min read
December 19, 2024

VALIDATION OF DISINFECTANT EFFICACY

Developing a local SOP is giving a detailed description of the requirements for disinfectant efficacy testing and validation of the method is extremely important, for which various methods can be used, which are given below. Test Method – The Time Contact Test The test will demonstrate the ability of the disinfectant to kill or inhibit a large population of organisms […]

0 7 min read
December 19, 2024

VALIDATION OF THE SURFACE ACTIVITY OF DISINFECTANTS

It is generally accepted that although the Time-Contact Test provides good evidence for the activity of a particular agent, the method does not take into account the physical factors that may effect the performance of the agent when applied to actual surface materials such as Stainless Steel, Vinyl, Ceramics, PVC, Perspex, Glass. There are a number of factors that may […]

0 5 min read