Tag: iq oq meaning

Trend Analysis of Hold Time Study Failures

Trend Analysis of Hold Time Study Failures Trend Analysis of Hold Time Study Failures In the pharmaceutical and biologics industries, maintaining the integrity and quality of products throughout their lifecycle is essential. Hold time studies are a critical component of…

Case Study: CPV Trend Leading to Process Optimization

Case Study: CPV Trend Leading to Process Optimization Case Study: CPV Trend Leading to Process Optimization In the pharmaceutical sector, Continued Process Verification (CPV) has emerged as a key component in ensuring product quality and compliance with regulatory standards. This…

Pressure Differentials and Door Interlock Validation

Pressure Differentials and Door Interlock Validation Pressure Differentials and Door Interlock Validation In the pharmaceutical and biologic industries, ensuring process validation through rigorous protocols is essential. This article presents a comprehensive, step-by-step tutorial on the validation lifecycle, focusing on pressure…

QA Checklist for Closing Change Control Revalidation Records

QA Checklist for Closing Change Control Revalidation Records QA Checklist for Closing Change Control Revalidation Records The validation lifecycle is critical for ensuring compliance with regulatory guidance and achieving product quality. This article provides a comprehensive, step-by-step tutorial on the…

Using Risk Strategy to Justify Test Reductions in PQ

Using Risk Strategy to Justify Test Reductions in PQ Using Risk Strategy to Justify Test Reductions in PQ: A Step-by-Step Validation Tutorial In the pharmaceutical industry, the need for effective validation is paramount, particularly in the context of process qualification…

Troubleshooting High LOD/LOQ in Degradation Product Methods

Troubleshooting High LOD/LOQ in Degradation Product Methods Troubleshooting High LOD/LOQ in Degradation Product Methods In the pharmaceutical industry, analytical method validation is crucial for ensuring that degradation product methods provide reliable and accurate measurements of Limit of Detection (LOD) and…

Impact of Gas Contamination on Product Quality

Impact of Gas Contamination on Product Quality Impact of Gas Contamination on Product Quality In the pharmaceutical and biotech industries, ensuring the quality of products is paramount. Contamination from gases, especially in processes reliant on compressed air or nitrogen, can…

How to Determine Normal Operating and Proven Acceptable Ranges

How to Determine Normal Operating and Proven Acceptable Ranges How to Determine Normal Operating and Proven Acceptable Ranges Determining Normal Operating Ranges (NOR) and Proven Acceptable Ranges (PAR) is a critical step in the process validation lifecycle of pharmaceutical and…