Tag: eudralex annex 11

KPI Approval Workflows: Who Owns What Metrics?

KPI Approval Workflows: Who Owns What Metrics? KPI Approval Workflows: Who Owns What Metrics? In the pharmaceutical industry, the establishment and monitoring of Key Performance Indicators (KPIs) are crucial for ensuring compliance with regulatory standards such as the Eudralex Annex…

Linking CPV to Risk Management per ICH Q9

Linking CPV to Risk Management per ICH Q9 Linking CPV to Risk Management per ICH Q9 As pharmaceutical and biologics professionals face the increasing complexity of modern manufacturing processes, understanding the regulatory landscape becomes critical. The integration of Continued Process…

Regulatory Emphasis on Contamination Control Strategy (CCS)

Regulatory Emphasis on Contamination Control Strategy (CCS) Regulatory Emphasis on Contamination Control Strategy (CCS) As the pharmaceutical industry continues to evolve, the emphasis on effective contamination control strategies (CCS) remains paramount, especially in sterile manufacturing. The guidelines provided by Eudralex…

Using Product Quality Trends to Trigger Revalidation

Using Product Quality Trends to Trigger Revalidation Using Product Quality Trends to Trigger Revalidation In the pharmaceutical industry, maintaining compliance with regulatory standards is paramount for ensuring product quality. The process validation lifecycle comprises several critical steps that can significantly…

Handling Risk Documentation During Tech Transfers

Handling Risk Documentation During Tech Transfers Handling Risk Documentation During Tech Transfers In the pharmaceutical industry, effective risk management is crucial for ensuring compliance with regulatory standards and maintaining product quality. This article serves as a comprehensive step-by-step tutorial on…

Compiling Raw Data and Audit Trails for Validation Reports

Compiling Raw Data and Audit Trails for Validation Reports Compiling Raw Data and Audit Trails for Validation Reports In the highly regulated pharmaceutical industry, ensuring compliance with validation requirements is paramount. The process of compiling raw data and audit trails…

Utility Flow Path Verification Using Borescopes and P&IDs

Utility Flow Path Verification Using Borescopes and P&IDs Utility Flow Path Verification Using Borescopes and P&IDs Utility Flow Path Verification is critical in ensuring the integrity and proper functioning of utility systems within pharmaceutical manufacturing. This article serves as a…

How to Evaluate Edge of Failure and Normal Operating Ranges

How to Evaluate Edge of Failure and Normal Operating Ranges How to Evaluate Edge of Failure and Normal Operating Ranges The evaluation of the edge of failure and normal operating ranges is critical in ensuring that pharmaceutical processes remain within…