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 […]

Analytical Method Validation: An Overview

What is Analytical Method Validation? The FDA’s 1987 Process Validation Guidelines define analytical method validation as “the process of establishing documented evidence which provides a high degree of assurance that a specific process such as an analytical test method, will consistently produce a product supported by assay results meeting its predetermined specifications and quality attributes (i.e., accuracy, precision, etc.)” To […]