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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 3, 2025

SOP for Analytical Weighing Balances in the Pharmaceutical Industry

In the pharmaceutical industry, precision and accuracy are paramount. Analytical weighing balances play a critical role in ensuring compliance with regulatory standards, maintaining quality, and delivering reliable results. A well-documented Standard Operating Procedure (SOP) for analytical weighing balances is essential for consistent operations and adherence to Good Laboratory Practices (GLP). This article outlines the key components of an SOP for […]

0 3 min read
January 28, 2025

Standard Operating Procedure (SOP) Determination of Residual Hydrocarbon Content in Pharmaceutical Gases

1. Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the method for the determination of residual hydrocarbon content in pharmaceutical gases used in manufacturing processes. The accurate quantification of hydrocarbons ensures compliance with regulatory standards and maintains the quality of pharmaceutical products. 2. Scope This SOP applies to the analysis of residual hydrocarbon content in pharmaceutical […]

0 3 min read
December 23, 2024

SOP for Handling of Feeding Area in Pharmaceutical Industries

Header of Facility/Industry/Company Should bear the Following contents Document Number: (To be given as Per Nomenclature) Effective Date: (To be given ) Review Date: (To be given) Version Number: (To be given as Per Nomenclature) Prepared By: (Name/Designation as per SOP) Approved By: (Name/Designation as per SOP) 1. Purpose: In this document the pharmaceutical industry is presented with guidelines on […]

0 3 min read