Tag: iso 11607 2

Cloud-Based KPI Systems for Cross-Site Validation Oversight

Cloud-Based KPI Systems for Cross-Site Validation Oversight Cloud-Based KPI Systems for Cross-Site Validation Oversight This article serves as a comprehensive guide for pharmaceutical professionals focusing on the validation lifecycle, particularly in the context of ISO 11607-2. Throughout this tutorial, we…

Using Excel Dashboards for Manual KPI Monitoring

Using Excel Dashboards for Manual KPI Monitoring Using Excel Dashboards for Manual KPI Monitoring In the pharmaceutical and biotech industries, compliance with regulatory standards such as ICH Q8–Q10, FDA Process Validation Guidance, and EU GMP Annex 15 is vital. Key…

CPV Observations in FDA 483s and Warning Letters

CPV Observations in FDA 483s and Warning Letters Continued Process Verification (CPV) has become increasingly critical in ensuring the ongoing quality and compliance of pharmaceutical manufacturing processes. The CPV framework emphasizes continuous assessment and validation of manufacturing processes based on…

Preparing CPV Documentation for Regulatory Inspections

Preparing CPV Documentation for Regulatory Inspections Preparing CPV Documentation for Regulatory Inspections Continued Process Verification (CPV) is a crucial element in the lifecycle management of pharmaceutical manufacturing processes. It aims to ensure that processes remain in a state of control…

Preparing for an Aseptic Process Inspection: Checklist

Preparing for an Aseptic Process Inspection: Checklist Preparing for an Aseptic Process Inspection: Checklist Ensuring compliance with regulatory standards for aseptic processes is vital for pharmaceutical manufacturers. This article provides a comprehensive, step-by-step tutorial on preparing for an aseptic process…

WHO and PIC/S Guidelines on Sterile Product Validation

WHO and PIC/S Guidelines on Sterile Product Validation WHO and PIC/S Guidelines on Sterile Product Validation Step 1: Understanding the Importance of ISO 11607-2 The ISO 11607-2 standard is integral to the validation of packaging for terminally sterilized medical devices.…

Linking Continued Process Verification (CPV) to Revalidation Triggers

Linking Continued Process Verification (CPV) to Revalidation Triggers Linking Continued Process Verification (CPV) to Revalidation Triggers In the evolving landscape of pharmaceutical manufacturing, ensuring consistent product quality is of utmost importance. This is particularly true when we examine Continued Process…

Tools to Score and Prioritize Revalidation Activities

Tools to Score and Prioritize Revalidation Activities Tools to Score and Prioritize Revalidation Activities In today’s pharmaceutical landscape, the implementation of systematic validation processes is critical. One key area often demanding particular attention is the revalidation activities, especially concerning compliance…

Linking Risk Files to Change Control and Revalidation SOPs

Linking Risk Files to Change Control and Revalidation SOPs Linking Risk Files to Change Control and Revalidation SOPs This article provides a comprehensive, step-by-step tutorial on the critical aspects of validation in the pharmaceutical industry, focusing on the integration of…

How to Update Risk Assessments Post-Validation

How to Update Risk Assessments Post-Validation How to Update Risk Assessments Post-Validation Step 1: Understanding Risk Assessment Frameworks The foundation of a robust validation strategy begins with effective risk assessments, particularly through frameworks outlined in ISO 11607-2 and related guidelines…