Tag: instrument validation

Digital Tools for Real-Time Validation Status Tracking

Digital Tools for Real-Time Validation Status Tracking Digital Tools for Real-Time Validation Status Tracking Step 1: User Requirements Specification (URS) & Risk Assessment The foundation of any effective validation process begins with a well-defined User Requirements Specification (URS). This document…

How to Perform Trend Analysis in CPV Programs

How to Perform Trend Analysis in CPV Programs How to Perform Trend Analysis in CPV Programs Continued Process Verification (CPV) is a critical component of the lifecycle management of a pharmaceutical product, ensuring consistency and quality throughout its commercial lifecycle.…

How to Build a Sterility Assurance Program in Pharma

How to Build a Sterility Assurance Program in Pharma How to Build a Sterility Assurance Program in Pharma In the pharmaceutical industry, a Sterility Assurance Program (SAP) is essential for ensuring that products meant for human use are free from…

Change Control Workflow Template for Validation Projects

Change Control Workflow Template for Validation Projects Change Control Workflow Template for Validation Projects In the pharmaceutical industry, maintaining compliance across various validation protocols is crucial for the development and manufacturing of safe and effective products. The process of instrument…

Defining Critical vs Non-Critical Equipment for Validation

Defining Critical vs Non-Critical Equipment for Validation Defining Critical vs Non-Critical Equipment for Validation This article serves as a comprehensive guide for pharmaceutical professionals in the realm of instrument validation, defining critical versus non-critical equipment within the context of GMP…

Ruggedness Testing Using Inter-Laboratory Variations

Ruggedness Testing Using Inter-Laboratory Variations Ruggedness Testing Using Inter-Laboratory Variations As pharmaceutical and biologics professionals, understanding the importance of robust instrument validation during analytical method development is critical to maintain compliance with regulatory guidelines. This tutorial provides a comprehensive step-by-step…

Conductivity and TOC Testing in Water System Validation

Conductivity and TOC Testing in Water System Validation Conductivity and TOC Testing in Water System Validation Water systems play a crucial role in pharmaceutical manufacturing, where the quality of water directly impacts the safety and efficacy of the final products.…

Equipment Downtime and Impact on Holding Time: Mitigation Strategies

Equipment Downtime and Impact on Holding Time: Mitigation Strategies Equipment Downtime and Impact on Holding Time: Mitigation Strategies In the pharmaceutical industry, ensuring product quality and compliance with regulatory requirements is essential. A critical aspect of this is the validation…