Publications

Downloadable Supplier Assessment Questionnaire

October 14, 2025

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 […]

Publications

Rx-360 Technical Visit Guidelines for the Biopharmaceutical Industry

October 13, 2025

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 […]

Patient Safety Blog

Clarifying QMS Relevancy: Why We Need Industry Guidance Now

September 18, 2025

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 […]

Publications

SCAR – Supplier Corrective Action Report Programs: A Practical Guide Developed by the Supplier Quality Working Group

July 30, 2025

‘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 […]

Publications

Supplier Assessment Questionnaire

April 3, 2024

The web-based Supplier assessment questionnaire is now live Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment […]

Rx-360 Insights

Rx-360 Releases Two New Publications in Support of the Pharmaceutical Industry and Patient Safety

November 14, 2023

Rx-360 is pleased to announce that the consortium membership led by key members of the Supplier Quality Working Group have released two new papers this week to help drive best practices in pharmaceutical supply chain integrity and patient safety.

Publications

Managing Critical Vendors Version 2.0

November 10, 2023

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 process […]

Publications

Quality Elements for Suppliers of Products or Services to GMP Regulated Companies

Medical products are items used to diagnose, treat, cure, mitigate or prevent disease in patients. These include pharmaceutical products and medical devices. The manufacture of medical products that are used in the United States, and […]

Publications

Rx-360 Best Practices Quality Agreement Guide

November 17, 2022

This Best Practices Quality Agreement Guide is intended to assist both Customers and Suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements. “Supplier” is used broadly in this document to […]