Tag: pharmaceutical validation

Handling Non-Compliant Legacy Equipment: Mitigation Plans

Handling Non-Compliant Legacy Equipment: Mitigation Plans Handling Non-Compliant Legacy Equipment: Mitigation Plans Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The initial stage in the pharmaceutical validation lifecycle involves developing a User Requirements Specification (URS) and conducting a…

Real-Time Data Collection Systems for CPV Monitoring

Real-Time Data Collection Systems for CPV Monitoring Real-Time Data Collection Systems for CPV Monitoring Continued Process Verification (CPV) is a vital stage in the lifecycle of pharmaceutical validation that ensures ongoing compliance and product quality. This tutorial outlines a sequential…

How to Align Stage 2 Validation with Cleaning and Equipment Readiness

How to Align Stage 2 Validation with Cleaning and Equipment Readiness How to Align Stage 2 Validation with Cleaning and Equipment Readiness Pharmaceutical validation is a crucial aspect of ensuring that manufacturing processes produce consistent, high-quality products. Stage 2 validation,…

How Many PPQ Batches Are Required? Regulatory Views

How Many PPQ Batches Are Required? Regulatory Views How Many PPQ Batches Are Required? Regulatory Views In the pharmaceutical industry, pharmaceutical validation is a critical process that assures the efficacy, safety, and quality of medicinal products. When it comes to…