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 results, thereby influencing batch release decisions. In this article, we provide a comprehensive step-by-step validation tutorial focusing on the critical aspects of SST, criteria for repetition, and its impact on batch release. This guide is aligned with globally recognized regulatory guidelines, including the FDA Process Validation Guidance, EU GMP Annex 15, ICH Q8–Q10, and ICH Q9. Professionals in Quality Assurance,…

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 critical for verifying method performance, particularly regarding specificity, accuracy, and reliability. Placebo samples are matrices that contain all components of the formulation except the analyte of interest, while spiked samples incorporate a known quantity of the analyte into a matrix to assess recovery and other performance characteristics. These samples play essential roles in method transfer by providing benchmarks against which…

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 detailed steps of validation, specifically focusing on managing instrument variation. Our objective is to ensure compliance with the FDA Process Validation Guidance, EU GMP Annex 15, and ICH guidelines, facilitating effective quality assurance and quality control among QA, QC, validation, and regulatory teams across the US, UK, and EU. Step 1: Understanding User Requirements Specification (URS) and Risk Assessment Initial…

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 frameworks including GMP standards. Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first critical step in the validation lifecycle is the formulation of a User Requirements Specification (URS) followed by a thorough risk assessment. The URS must clearly define the intended use of the validated method, ensuring that it meets both operational and regulatory requirements. This document…

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 step-by-step approach to address system suitability test (SST) failures, focusing on root cause analysis and corrective and preventive actions (CAPA). The intended audience includes professionals in Quality Assurance (QA), Quality Control (QC), and regulatory affairs across the US, UK, and EU. This document complies with guidelines provided by the FDA, EMA, and ICH, particularly those relating to the use of…

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 to guide professionals in conducting a thorough analytical method transfer risk assessment, focusing on the ISO 14644 cleanroom standards which are critical for maintaining compliance with GMP, FDA, and EMA guidelines. Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The first crucial step in the method transfer process begins with developing a User Requirements Specification (URS). The URS…

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 Regulatory teams focused on the validation lifecycle, particularly in relation to the master validation plan medical device. Emphasizing compliance with relevant regulatory guidelines—including FDA and EMA standards—we delve into practical aspects of system suitability checks that align with ISO 14644 specifications and other applicable cleanroom standards. Step 1: Define User Requirements and Risk Assessment The foundation of any validation process…

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 article provides a comprehensive step-by-step tutorial on verifying method transfer using equivalency testing aligned with regulatory expectations from the FDA, EMA, and ICH. The focus will be extensive on key processes such as process design, qualification, performance qualification (PQ), continued process verification (CPV), and revalidation. Step 1: Understanding User Requirements and Risk Assessment To begin the method transfer process, the…

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 Good Manufacturing Practices (GMP) and other regulatory requirements. This article serves as a step-by-step tutorial on test method validation, outlining the processes necessary to transfer methods effectively while maintaining product quality and regulatory compliance. Step 1: Understand User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle is to develop a comprehensive User Requirements Specification (URS)….

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. System Suitability Testing (SST) is an essential part of method validation, ensuring that the analytical method performs as intended throughout its lifecycle. This article provides a comprehensive step-by-step guide to SST results trending and control charting, focusing specifically on the dry transfer western blot technique while aligning with FDA and EMA guidelines. Step 1: Understanding System Suitability Requirements The first…