Category: Analytical Method Validation

SST Failures: Root Cause Analysis and CAPA Approach

SST Failures: Root Cause Analysis and CAPA Approach SST Failures: Root Cause Analysis and CAPA Approach In the highly regulated pharmaceutical industry, validation processes are pivotal to ensuring product quality and compliance with established standards. This comprehensive guide outlines a…

Analytical Method Transfer Risk Assessment Template

Analytical Method Transfer Risk Assessment Template Analytical Method Transfer Risk Assessment Template The process of transferring analytical methods, particularly in the pharmaceutical industry, must be executed with precision and a comprehensive understanding of quality assurance regulations. This step-by-step tutorial aims…

Audit-Ready Documentation for System Suitability Checks

Audit-Ready Documentation for System Suitability Checks Audit-Ready Documentation for System Suitability Checks System suitability checks are a fundamental aspect of ensuring that analytical methods deliver reliable and consistent results. This article provides a step-by-step tutorial for QA, QC, Validation, and…

Verification of Method Transfer Using Equivalency Testing

Verification of Method Transfer Using Equivalency Testing Verification of Method Transfer Using Equivalency Testing In the pharmaceutical industry, the validation of analytical methods is crucial, particularly when transferring methods from one laboratory to another or from development to production. This…

Challenges in Method Transfer Across Global Sites

Challenges in Method Transfer Across Global Sites Challenges in Method Transfer Across Global Sites In the highly regulated pharmaceutical and medical device industries, method transfer between global sites poses significant challenges that must be meticulously addressed to ensure compliance with…

SST Results Trending and Control Charting in QC Labs

SST Results Trending and Control Charting in QC Labs SST Results Trending and Control Charting in QC Labs In the pharmaceutical and biopharmaceutical industry, ensuring the reliability and robustness of analytical methods is critical for regulatory compliance and product quality.…

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…