Tag: eu gmp annex 11

Validation Failure Reduction Through Trend Monitoring

Validation Failure Reduction Through Trend Monitoring Validation Failure Reduction Through Trend Monitoring In the dynamically evolving pharmaceutical landscape, validation practices play a pivotal role in ensuring product quality, compliance, and patient safety. This step-by-step guide offers pharmaceutical professionals a comprehensive…

Cross-Site CPV Reviews and Benchmarking Practices

Cross-Site CPV Reviews and Benchmarking Practices Cross-Site CPV Reviews and Benchmarking Practices Continued Process Verification (CPV) has emerged as a critical component of quality assurance in pharmaceutical manufacturing, particularly in light of the evolving regulatory landscape outlined in EU GMP…

Integration of Equipment and Personnel Qualification in Process PQ

Integration of Equipment and Personnel Qualification in Process PQ Integration of Equipment and Personnel Qualification in Process PQ In the realm of pharmaceutical validation, especially within the context of aseptic processes, integration of equipment and personnel qualification forms the backbone…

Revalidation Approval Matrix for QA, Validation, and Engineering

Revalidation Approval Matrix for QA, Validation, and Engineering Revalidation Approval Matrix for QA, Validation, and Engineering In the pharmaceutical and biologics sectors, validation is crucial for ensuring quality, safety, and efficacy. The revalidation process, encompassing the lifecycle of validation from…

Writing a Risk-Based Validation SOP

Writing a Risk-Based Validation SOP Writing a Risk-Based Validation SOP Step 1: Understanding the Validation Lifecycle In the context of pharmaceutical manufacturing, process validation embodies a critical framework for ensuring that manufacturing processes perform consistently within predetermined specifications. The validation…

Case Studies of Audit Observations on LOD/LOQ Validation

Case Studies of Audit Observations on LOD/LOQ Validation Case Studies of Audit Observations on LOD/LOQ Validation Validation of analytical methods is critical for ensuring the reliability and accuracy of test results in the pharmaceutical sector. This article presents a step-by-step…

Common Gaps Found During Gas System Audits

Common Gaps Found During Gas System Audits Common Gaps Found During Gas System Audits This article provides a comprehensive, step-by-step guide on identifying and addressing common gaps found during gas system audits, specifically focusing on compliance with EU GMP Annex…

Cross-functional Roles in Setting and Verifying Process Ranges

Cross-functional Roles in Setting and Verifying Process Ranges Cross-functional Roles in Setting and Verifying Process Ranges In the highly regulated pharmaceutical industry, ensuring process validation is a critical step in the lifecycle of drug development. The validation of processes not…