Strengthening Patient Safety Through Practical Supplier Quality Oversight | Insights from an Rx‑360 Supplier Quality Working Group Informal Survey
Ensuring patient safety depends on the integrity of global pharmaceutical supply chains—yet Supplier Quality professionals continue to face practical, structural challenges in how audits are conducted, documented, and leveraged for assurance. To better understand current practices, Rx‑360 […]
Supplier Corrective Action Report Web Form
Optimize Supplier Corrective Actions with Rx‑360’s SCAR Template The Supplier Quality Working Group at Rx‑360 has developed a standardized Supplier Corrective Action Report (SCAR) template designed to strengthen pharmaceutical supply chain integrity and improve quality […]
Downloadable Supplier Assessment Questionnaire
simplify supplier assessments using Rx-360’s SAQ Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously […]
Rx-360 Technical Visit Guidelines for the Biopharmaceutical Industry
Get guidance from subject matter experts on the requirements, execution, and management of the “technical visit”, as a tool in the supplier quality manager’s toolbox, and as it compares to the “quality audit”. The publication […]
SAQ
Clarifying QMS Relevancy: Why We Need Industry Guidance Now
In the world of regulated industries—Quality Management Systems (QMS) are the backbone of consistent, safe, and effective operations. But here’s the catch: the language in ISO and other standards often leaves too much room for […]
SCAR – Supplier Corrective Action Report Programs: A Practical Guide Developed by the Supplier Quality Working Group
‘SCAR’ gives pharmaceutical industry professionals a framework for handling improvements that they demand from their suppliers (i.e., vendors) based on regulations and/or the outsourcing entity’s own quality standards. This guide includes a template SCAR form […]
Rx-360 Technical Visit Guidelines for the Regulated Medical Product Industry Upstream Supply Chain
Supplier qualification audits and supplier technical visits are part of routine operations when working in the pharmaceutical or biotech industry. Many times, technical visits and audits are confused with one another because there is some […]
Managing Critical Vendors
Introduction: The manufacture of medical products, drugs and devices is highly regulated all over the world. All aspects of the manufacturing process, from product design to product delivery, require documented procedures. Key points in the […]
Rx-360 Natural Disaster Contingency Planning
As we read the news around the world it almost seems that there is some sort of natural disaster occurring. Hurricanes, monsoons, earthquakes are occurring around the world and when they do they have an […]