Tag: iso14644 3

Linking Cleaning Validation Failures to Trend Metrics

Linking Cleaning Validation Failures to Trend Metrics Linking Cleaning Validation Failures to Trend Metrics In the highly regulated pharmaceutical and biologics sectors, adherence to stringent validation requirements ensures the safety, efficacy, and quality of products. One critical area of focus…

CPV in Annual Product Quality Reviews (APQR/PQR)

CPV in Annual Product Quality Reviews (APQR/PQR) CPV in Annual Product Quality Reviews (APQR/PQR) Continued Process Verification (CPV) is an essential component of the annual product quality review (APQR) process in the pharmaceutical industry, ensuring product quality and regulatory compliance.…

Simulating Worst-Case Conditions in Aseptic Qualification

Simulating Worst-Case Conditions in Aseptic Qualification Simulating Worst-Case Conditions in Aseptic Qualification This article provides a comprehensive, step-by-step tutorial on simulating worst-case conditions during aseptic qualification in compliance with current regulatory frameworks such as FDA, EMA, and ISO standards. It…

Review and Approval Log for Revalidation Activities

Review and Approval Log for Revalidation Activities Review and Approval Log for Revalidation Activities In the pharmaceutical and biologics industries, ensuring that validated processes remain in a state of control throughout their lifecycle is crucial. This article provides a comprehensive,…

How to Link Risk Assessment to Validation Protocol Design

How to Link Risk Assessment to Validation Protocol Design How to Link Risk Assessment to Validation Protocol Design In the pharmaceutical and biological industries, ensuring the quality and safety of products through rigorous validation processes is non-negotiable. The integration of…

Validation Criteria for LOD and LOQ: What Is Acceptable?

Validation Criteria for LOD and LOQ: What Is Acceptable? Validation Criteria for LOD and LOQ: What Is Acceptable? Validation of analytical methods concerning the limit of detection (LOD) and limit of quantification (LOQ) is critical in the pharmaceutical and biotechnology…

Compressed Nitrogen Qualification for Use in Cleanrooms

Compressed Nitrogen Qualification for Use in Cleanrooms Compressed Nitrogen Qualification for Use in Cleanrooms In the pharmaceutical and biologics sectors, the qualification of utility gases, such as compressed nitrogen, is critical to ensure compliance with rigorous regulatory expectations aimed at…

Understanding Process Capability in Pharmaceutical Validation

Understanding Process Capability in Pharmaceutical Validation Understanding Process Capability in Pharmaceutical Validation Process capability is an essential consideration in pharmaceutical validation, especially when aligning with regulatory standards such as ISO 14644-3. This step-by-step guide aims to provide QA, QC, and…