Tag: oq pq

Validation Report Audit Checklist: KPIs to Include

Validation Report Audit Checklist: KPIs to Include Validation Report Audit Checklist: KPIs to Include Step 1: Understanding the Validation Lifecycle The validation lifecycle is a structured framework essential for ensuring that processes within pharmaceutical and medical device manufacturing align with…

How to Build CPV Alerts Based on Historical Trends

How to Build CPV Alerts Based on Historical Trends How to Build CPV Alerts Based on Historical Trends Continued Process Verification (CPV) is a crucial element in ensuring the quality and compliance of pharmaceutical processes. By leveraging historical data trends,…

UV Tunnel and Surface Decontamination Unit Validation

UV Tunnel and Surface Decontamination Unit Validation UV Tunnel and Surface Decontamination Unit Validation In the pharmaceutical industry, ensuring the integrity of aseptic processes is paramount. The validation of UV tunnel and surface decontamination units is crucial to maintaining compliance…

Preparing Revalidation Justifications for NDA/ANDA Filings

Preparing Revalidation Justifications for NDA/ANDA Filings Preparing Revalidation Justifications for NDA/ANDA Filings Revalidation is a critical process in the lifecycle of pharmaceutical manufacturing and must be meticulously planned and executed to meet regulatory expectations. This article provides a detailed step-by-step…

ICH Q9 Flowchart Adapted for Validation Teams

ICH Q9 Flowchart Adapted for Validation Teams ICH Q9 Flowchart Adapted for Validation Teams In the pharmaceutical and biologics industries, validation is a critical component of ensuring product quality and compliance with regulatory standards. This comprehensive guide focuses on the…

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…

Bio-Burden and Endotoxin Control in Clean Steam

Bio-Burden and Endotoxin Control in Clean Steam Bio-Burden and Endotoxin Control in Clean Steam In pharmaceutical and biologics manufacturing, managing bio-burden and endotoxin levels is crucial, particularly when dealing with clean steam systems. This article provides a comprehensive, step-by-step validation…

Blend Uniformity Testing Protocol: A Step-by-Step Guide

Blend Uniformity Testing Protocol: A Step-by-Step Guide Blend Uniformity Testing Protocol: A Step-by-Step Guide Ensuring blend uniformity is critical in the pharmaceutical manufacturing process, particularly when preparing products that require stringent quality standards. This comprehensive guide provides a detailed, step-by-step…