Tag: analytical method validation

Acceptance Criteria for Resolution, Tailing, and Theoretical Plates

Acceptance Criteria for Resolution, Tailing, and Theoretical Plates Acceptance Criteria for Resolution, Tailing, and Theoretical Plates Analytical method validation is a critical component of pharmaceutical quality assurance, ensuring that methods used for testing meet the necessary regulatory standards. This article…

Writing a Protocol for Analytical Method Transfer

Writing a Protocol for Analytical Method Transfer Writing a Protocol for Analytical Method Transfer Transferring analytical methods from one laboratory to another or from development to routine use is a critical step in ensuring that quality control and quality assurance…

Linking the VMP to GxP Requirements and Quality Systems

Linking the VMP to GxP Requirements and Quality Systems Linking the VMP to GxP Requirements and Quality Systems Step 1: Understanding the Validation Master Plan (VMP) The Validation Master Plan (VMP) serves as a comprehensive document outlining the approach and…

Method Transfer vs Method Validation: Understanding the Differences

Method Transfer vs Method Validation: Understanding the Differences Method Transfer vs Method Validation: Understanding the Differences The validation of analytical procedures is a critical aspect of pharmaceutical development, ensuring the reliability and accuracy of testing methods. This tutorial aims to…

Common SST Failures and How to Troubleshoot Them

Common SST Failures and How to Troubleshoot Them Common SST Failures and How to Troubleshoot Them The validation of analytical procedures is a critical component of pharmaceutical quality assurance in compliance with regulatory standards like the FDA guidelines, EU GMP…

USP and EP Criteria for System Suitability Parameters

USP and EP Criteria for System Suitability Parameters USP and EP Criteria for System Suitability Parameters This article serves as a comprehensive tutorial on the validation process for analytical methods, focusing primarily on the criteria for system suitability parameters according…

LOD and LOQ Qualification in Residual Cleaning Validation

LOD and LOQ Qualification in Residual Cleaning Validation LOD and LOQ Qualification in Residual Cleaning Validation In the realm of pharmaceutical quality assurance, ensuring that products are free from contaminants is crucial to patient safety and regulatory compliance. One significant…

Case Studies of Audit Observations on LOD/LOQ Validation

Case Studies of Audit Observations on LOD/LOQ Validation Case Studies of Audit Observations on LOD/LOQ Validation Validation of analytical methods is critical for ensuring the reliability and accuracy of test results in the pharmaceutical sector. This article presents a step-by-step…

Analytical Method Transfer Issues Related to LOD and LOQ

Analytical Method Transfer Issues Related to LOD and LOQ Analytical Method Transfer Issues Related to LOD and LOQ: A Step-by-Step Validation Guide In the pharmaceutical industry, ensuring the reliability and accuracy of analytical methods is critical for regulatory compliance and…