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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 16, 2025

Implementing CPPs and CQAs for Robust Vaccine Manufacturing

The production of high-quality vaccines hinges on the meticulous control of Critical Process Parameters (CPPs) and the rigorous monitoring of Critical Quality Attributes (CQAs). CPPs are the key variables within the manufacturing process that directly impact vaccine quality, while CQAs are the essential properties that must meet predefined limits to ensure safety and efficacy. The interplay between these two is […]

0 3 min read

February 11, 2025

Best Practices in Pharmaceutical Drainage and Drain Control

Introduction Effective drainage systems are crucial in pharmaceutical manufacturing facilities. Drains are essential for removing water from plants, equipment, and facilities, preventing flooding and maintaining a safe and hygienic environment. However, they also represent a potential source of microbiological contamination. The risk of backflow from drains into production areas must be a primary consideration during the design phase of new […]

0 2 min read

February 4, 2025

Audit Trail Requirements in Pharmaceuticals

Introduction Every pharmaceutical enterprise needs to maintain strict precision and follow regulations at all times. A complete audit trail acts as the primary defense mechanism for protecting data integrity. Every pharmaceutical company needs audit trails to perform their work correctly. An audit trail is a digital record that stores every data action while keeping records private and meeting official rules. […]

0 4 min read