Continued Process Verification (CPV)

QA Oversight in Reviewing CPV Strategy Across Lifecycle

QA Oversight in Reviewing CPV Strategy Across Lifecycle QA Oversight in Reviewing CPV Strategy Across Lifecycle In the ever-evolving landscape of pharmaceutical manufacturing, Continued Process Verification (CPV) serves as a key element in ensuring consistent product quality and compliance with…

Real-Time Monitoring and Its Impact on Lifecycle Verification

Real-Time Monitoring and Its Impact on Lifecycle Verification Real-Time Monitoring and Its Impact on Lifecycle Verification Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The first step in the validation lifecycle is developing a robust User Requirements Specification…

What Data to Monitor in CPV: CPPs, CQAs, and Beyond

What Data to Monitor in CPV: CPPs, CQAs, and Beyond What Data to Monitor in CPV: CPPs, CQAs, and Beyond In the pharmaceutical and biopharmaceutical industries, Continued Process Verification (CPV) has emerged as a critical component of the overall validation…

Establishing Control Charts and Process Capability (Cp, Cpk)

Establishing Control Charts and Process Capability (Cp, Cpk) Establishing Control Charts and Process Capability (Cp, Cpk) In the pharmaceutical and biologics industries, demonstrating control over manufacturing processes is critical for ensuring product quality and compliance with regulatory expectations. One effective…

How to Perform Trend Analysis in CPV Programs

How to Perform Trend Analysis in CPV Programs How to Perform Trend Analysis in CPV Programs Continued Process Verification (CPV) is a critical component of the lifecycle management of a pharmaceutical product, ensuring consistency and quality throughout its commercial lifecycle.…

CPV Data Sources: MES, LIMS, BMRs, and Manual Logs

CPV Data Sources: MES, LIMS, BMRs, and Manual Logs CPV Data Sources: MES, LIMS, BMRs, and Manual Logs Continued Process Verification (CPV) has become an essential part of the pharmaceutical manufacturing lifecycle, allowing companies to ensure that their processes remain…

Real-Time Data Collection for Batch-to-Batch Consistency

Real-Time Data Collection for Batch-to-Batch Consistency Real-Time Data Collection for Batch-to-Batch Consistency Continued Process Verification (CPV) is essential in ensuring product quality and compliance in the pharmaceutical industry. Among its key elements is cleaning validation, which is critical to avoiding…

Setting Statistical Action and Alert Limits in CPV

Setting Statistical Action and Alert Limits in CPV Setting Statistical Action and Alert Limits in CPV Continued Process Verification (CPV) is an essential component of the pharmaceutical validation lifecycle, intended to ensure that processes remain in a state of control…

Integration of SCADA/PLC Outputs into CPV Dashboards

Integration of SCADA/PLC Outputs into CPV Dashboards Integration of SCADA/PLC Outputs into CPV Dashboards In the pharmaceutical industry, the integration of SCADA (Supervisory Control and Data Acquisition) and PLC (Programmable Logic Controller) outputs into Continued Process Verification (CPV) dashboards is…

Out-of-Trend (OOT) vs Out-of-Specification (OOS) in CPV

Out-of-Trend (OOT) vs Out-of-Specification (OOS) in CPV Out-of-Trend (OOT) vs Out-of-Specification (OOS) in CPV In the context of pharmaceutical manufacturing, maintaining quality control through continued process verification (CPV) is imperative. A critical aspect of CPV relates to the monitoring and…