Ongoing Vendor and Material Monitoring

Material Quality Trending to Predict Vendor Issues

Material Quality Trending to Predict Vendor Issues Material Quality Trending to Predict Vendor Issues The pharmaceutical industry operates within stringent regulatory frameworks that necessitate robust validation practices. One pivotal aspect of ensuring product quality and compliance is the validation of…

How to Track On-Time Delivery, Rejections, and Deviations

How to Track On-Time Delivery, Rejections, and Deviations How to Track On-Time Delivery, Rejections, and Deviations The pharmaceutical industry requires rigorous validation of processes and systems to ensure the quality and compliance of biopharmaceutical production. One critical aspect of this…

Supplier Management SOP with Monitoring Provisions

Supplier Management SOP with Monitoring Provisions Supplier Management SOP with Monitoring Provisions In the pharmaceutical and biopharmaceutical industries, effective supplier management is paramount to ensure compliance with regulatory standards, including ISO 14644-1 Class 5, EU GMP Annex 11 for computerised…

Cross-Site Vendor Performance Benchmarking

Cross-Site Vendor Performance Benchmarking Cross-Site Vendor Performance Benchmarking This article provides a detailed step-by-step tutorial on the validation lifecycle as it pertains to cross-site vendor performance benchmarking in compliance with EU GMP Annex 15 and related regulations. The focus is…

Handling Sudden Vendor Termination or Quality Drops

Handling Sudden Vendor Termination or Quality Drops Handling Sudden Vendor Termination or Quality Drops In the challenging landscape of pharmaceutical and medical device manufacturing, the implications of vendor termination or quality drops can significantly affect product quality and regulatory compliance.…

Vendor Monitoring Tools and Software for GxP Use

Vendor Monitoring Tools and Software for GxP Use Vendor Monitoring Tools and Software for GxP Use In the pharmaceutical, biotechnology, and medical device industries, the qualification and monitoring of vendors is critical to ensuring that products meet all required safety,…