Tag: iq oq pq validation

KPI Scorecards for Vendor Qualification Programs

KPI Scorecards for Vendor Qualification Programs KPI Scorecards for Vendor Qualification Programs In the pharmaceutical industry, ensuring compliance with regulatory requirements is paramount to maintaining product quality and safety. This article outlines a comprehensive step-by-step tutorial on the iq oq…

Developing a Risk-Based CPV Sampling Plan

Developing a Risk-Based CPV Sampling Plan Developing a Risk-Based CPV Sampling Plan In the pharmaceutical landscape, ensuring product quality is non-negotiable. With rigorous regulatory requirements, a robust sampling plan is essential during the Continued Process Verification (CPV) phase of the…

How to Document Positive Media Fill Results and Take CAPA

How to Document Positive Media Fill Results and Take CAPA How to Document Positive Media Fill Results and Take CAPA The validation of aseptic processes, particularly around media fill simulations, is a fundamental component of ensuring the sterility and integrity…

Regulatory Expectations for Periodic Revalidation Frequencies

Regulatory Expectations for Periodic Revalidation Frequencies Regulatory Expectations for Periodic Revalidation Frequencies In the pharmaceutical industry, maintaining compliance with regulatory expectations is crucial for ensuring product quality and safety. Periodic revalidation plays a significant role in lifecycle management, ensuring processes…

Writing SOPs for FMEA and HACCP in Pharma Facilities

Writing SOPs for FMEA and HACCP in Pharma Facilities Writing SOPs for FMEA and HACCP in Pharma Facilities This article provides a comprehensive step-by-step validation tutorial focusing on the essential aspects of SOP development for Failure Modes and Effects Analysis…

Best Practices for Accuracy Recovery Experiments in Pharma Labs

Best Practices for Accuracy Recovery Experiments in Pharma Labs Best Practices for Accuracy Recovery Experiments in Pharma Labs Accuracy recovery experiments are a fundamental aspect of analytical method validation, ensuring that pharmaceutical products are produced consistently and meet regulatory standards.…

Critical Alarms and Interlocks in HVAC Validation

Critical Alarms and Interlocks in HVAC Validation Critical Alarms and Interlocks in HVAC Validation The validation of heating, ventilation, and air conditioning (HVAC) systems is crucial in the pharmaceutical and biologics industries, where stringent regulations dictate the maintenance of controlled…

Microbiological Considerations in Holding Time Validation

Microbiological Considerations in Holding Time Validation Microbiological Considerations in Holding Time Validation The validation of holding times in pharmaceutical processes is a crucial aspect of ensuring product quality and safety. This step-by-step tutorial delineates the procedures involved in holding time…