Ongoing Vendor and Material Monitoring

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,…

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.…

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…

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…

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…

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…

Documenting Supplier Review Outcomes for Regulatory Audits

Documenting Supplier Review Outcomes for Regulatory Audits Documenting Supplier Review Outcomes for Regulatory Audits Supplier qualification is a critical aspect of ensuring the integrity and compliance of pharmaceutical products. In the pharmaceutical industry, particularly within the contexts of aseptic process…

Linking Vendor Performance to Supplier Ratings and Renewal

Linking Vendor Performance to Supplier Ratings and Renewal Linking Vendor Performance to Supplier Ratings and Renewal The pharmaceutical industry relies heavily on external suppliers for raw materials, components, and services. Maintaining compliance with stringent regulations while ensuring the performance of…

Managing Vendor CAPAs and Follow-Ups

Managing Vendor CAPAs and Follow-Ups Managing Vendor CAPAs and Follow-Ups Aseptic processing validation is critical in ensuring that pharmaceutical products maintain sterility throughout their lifespan. This article serves as a comprehensive, step-by-step validation tutorial aimed at professionals involved in the…

Monitoring Vendor Notification Compliance for Changes

Monitoring Vendor Notification Compliance for Changes Monitoring Vendor Notification Compliance for Changes In the pharmaceutical industry, ensuring compliance with regulatory requirements during the vendor qualification process is crucial. This article provides a comprehensive, step-by-step validation tutorial for monitoring vendor notification…