Tag: System Suitability & Method Transfer

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…

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…