Analytical Methods - Pharmaguidelines

Standard Operating Procedure: Change Management for Analytical Methods

This Standard Operating Procedure (SOP) details the comprehensive process for managing changes to analytical methods in a laboratory setting. It covers responsibilities, procedures for initiating and approving changes, validation requirements, implementation steps, and post-implementation review to ensure accuracy and compliance.

HPLC Method Transfer and Validation: Ensuring Quality Assurance

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High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique in various industries, including pharmaceuticals, food, environmental monitoring, and more. Ensuring the consistency and reliability of HPLC methods when transferring them between laboratories or instruments is of paramount importance. In this article, we delve into the world of HPLC method transfer and validation, highlighting their

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