Tag: process validation in pharma industry

What Triggers Revalidation in Pharma? A Complete Guide

What Triggers Revalidation in Pharma? A Complete Guide What Triggers Revalidation in Pharma? A Complete Guide In the pharmaceutical industry, maintaining the quality and integrity of products is critical throughout their lifecycle. Process validation encompasses multiple stages, including design, qualification,…

Combining Manual and Digital Systems for Document Tracking

Combining Manual and Digital Systems for Document Tracking Combining Manual and Digital Systems for Document Tracking In the highly regulated pharmaceutical industry, maintaining strict documentation control is crucial for ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines.…

Comparing FMEA vs HACCP in Validation Risk Management

Comparing FMEA vs HACCP in Validation Risk Management Comparing FMEA vs HACCP in Validation Risk Management In the pharmaceutical industry, achieving compliance and ensuring product quality remain paramount. Effective risk management is integral to process validation and operational excellence. Two…

How to Use FMEA in Pharma Validation: Step-by-Step

How to Use FMEA in Pharma Validation: Step-by-Step How to Use FMEA in Pharma Validation: Step-by-Step Process validation is a critical component in the pharmaceutical industry, ensuring that manufacturing processes consistently yield products that meet predetermined specifications. The integration of…

Change Management Strategy for VMP Updates and Revisions

Change Management Strategy for VMP Updates and Revisions Change Management Strategy for VMP Updates and Revisions In the dynamic environment of the pharmaceutical industry, maintaining a Validation Master Plan (VMP) that accurately reflects the current status and compliance of processes…

Specificity Testing in Analytical Method Validation: Regulatory Focus

Specificity Testing in Analytical Method Validation: Regulatory Focus Specificity Testing in Analytical Method Validation: Regulatory Focus Specificity testing is a critical aspect of analytical method validation, particularly within the pharmaceutical industry. This article provides a step-by-step tutorial dedicated to understanding…

How to Validate Accuracy in Analytical Methods: A Step-by-Step Guide

How to Validate Accuracy in Analytical Methods: A Step-by-Step Guide How to Validate Accuracy in Analytical Methods: A Step-by-Step Guide In the pharmaceutical industry, ensuring the accuracy of analytical methods is a critical component of the overall process validation in…

Managing Software Upgrades in a SaaS CSV Environment

Managing Software Upgrades in a SaaS CSV Environment Managing Software Upgrades in a SaaS CSV Environment In the dynamic landscape of the pharmaceutical industry, managing software upgrades in a Software as a Service (SaaS) environment poses unique challenges, particularly in…

Air Change Rate and Recovery Time Calculations for HVAC Validation

Air Change Rate and Recovery Time Calculations for HVAC Validation Air Change Rate and Recovery Time Calculations for HVAC Validation In the pharmaceutical industry, ensuring high-quality production environments is critical to maintaining product integrity and compliance with regulatory standards. HVAC…

HVAC System Validation in Pharma: Step-by-Step Guide

HVAC System Validation in Pharma: Step-by-Step Guide HVAC System Validation in Pharma: Step-by-Step Guide In the pharmaceutical industry, the validation of Heating, Ventilation, and Air Conditioning (HVAC) systems is crucial to ensure that environmental conditions for manufacturing processes are controlled…