Tag: analytical method validation

Criteria for Repeating SST and Impact on Batch Release

Criteria for Repeating SST and Impact on Batch Release Criteria for Repeating SST and Impact on Batch Release System Suitability Testing (SST) is an integral part of analytical method validation. It ensures that the analytical procedures provide consistent and accurate…

Role of Placebo and Spiked Samples in Method Transfer

Role of Placebo and Spiked Samples in Method Transfer Role of Placebo and Spiked Samples in Method Transfer Step 1: Understanding the Purpose of Placebo and Spiked Samples In analytical method validation, the use of placebo and spiked samples is…

Managing Instrument Variation in System Suitability Testing

Managing Instrument Variation in System Suitability Testing Managing Instrument Variation in System Suitability Testing In the realm of pharmaceutical analytics, the precision and accuracy of methodologies, including system suitability testing, remain paramount. In this comprehensive guide, we’ll delve into the…

Regulatory Guidance on Method Transfer and Equivalence

Regulatory Guidance on Method Transfer and Equivalence Regulatory Guidance on Method Transfer and Equivalence This article serves as a comprehensive step-by-step guide for pharmaceutical professionals navigating the complexities of method transfer and equivalence aligned with FDA Guidance and other regulatory…

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.…