Tag: validation software for pharma

Periodic Review SOPs with Revalidation Triggers

Periodic Review SOPs with Revalidation Triggers Periodic Review SOPs with Revalidation Triggers In the pharmaceutical and biotechnology industries, ensuring compliance with regulatory standards and maintaining the integrity of validation processes is paramount. This comprehensive guide outlines a step-by-step approach to…

Linking Revalidation to Quality Metrics and CPV Data

Linking Revalidation to Quality Metrics and CPV Data Linking Revalidation to Quality Metrics and CPV Data In the pharmaceutical industry, ensuring product quality and compliance with regulatory requirements is paramount. The validation lifecycle comprises several crucial steps: from process design…

ICH Q9 vs ISO 14971: Which Risk Framework to Use?

ICH Q9 vs ISO 14971: Which Risk Framework to Use? ICH Q9 vs ISO 14971: Which Risk Framework to Use? In the ever-evolving landscape of pharmaceutical development, robust risk management is critical to ensure product quality and patient safety. Regulatory…

How ICH Q9 Supports Lifecycle Validation Models

How ICH Q9 Supports Lifecycle Validation Models How ICH Q9 Supports Lifecycle Validation Models The validation lifecycle in the pharmaceutical and biologics industries is a critical component in ensuring product quality, safety, and efficacy. Adherence to regulatory frameworks such as…

Updating the VMP for ICH Q9 Risk Mapping

Updating the VMP for ICH Q9 Risk Mapping Updating the VMP for ICH Q9 Risk Mapping Effective validation practices are critically important in ensuring compliance with regulatory expectations in the pharmaceutical industry. This article serves as a comprehensive guide through…

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…

Common Deviations and Failures in Steam Validation

Common Deviations and Failures in Steam Validation Common Deviations and Failures in Steam Validation Effective validation of steam systems is crucial for compliance with regulatory requirements and ensuring the quality of pharmaceutical products. This step-by-step tutorial outlines the validation lifecycle,…

Audit Trail for Steam System Validation Activities

Audit Trail for Steam System Validation Activities Audit Trail for Steam System Validation Activities In the pharmaceutical and biologics sectors, validation of steam systems is critical to ensure product quality and compliance with stringent regulatory requirements. This step-by-step tutorial covers…