Publications

Guide to Investigations – A Collaborative Publication by the Rx-360 Latin America Working Group 

November 5, 2024

The purpose of this guide is to provide tools that enable suppliers and service providers of the Healthcare and Pharmaceutical Industry to carry out robust investigations of nonconformities that help determine the impact on the quality of the product involved and consequently, the potential adverse impact for the patient that uses that regulated product. This publication is available in three languages.

Publications

Cargo Security Risk Assessment and Planning for Global Operations

October 24, 2024

This whitepaper provides an overview of industry best practices for developing and implementing an effective conveyance
security program regardless of company size or prior experience with supply chain security issues.

Rx-360 Insights

Rx-360 Announces Approval as a Pilot Center of Excellence for the APEC Regulatory Harmonization Steering Committee

October 4, 2024

Rx-360® is pleased to announce that it has been accepted as a Pilot Center of Excellence (CoE) for the APEC Regulatory Harmonization Steering Committee. The pilot will be focused on the Global Medical Product Supply Chain Integrity Priority Work Area Roadmap.

Publications

Supplier Assessment Questionnaire

April 3, 2024

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 questionnaire. Suppliers routinely exhaust valuable resources continuously completing […]

Rx-360 Insights

Rx-360 Announces 2024 Board of Directors

January 2, 2024

Rx-360® is pleased to announce its 2024 Board of Directors. As a non-profit, the Board of Directors is positioned to continue driving the Rx-360® mission of pharmaceutical supply chain security, material quality, and patient safety. This announcement follows the organization’s successful growth in 2023.

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 […]

Uncategorized

Working Group Excerpts

October 6, 2023
Rx-360 Insights

Improve Supply Chain Security: An Overview of Our Supplier-Led Working Group’s Whitepapers

October 5, 2023

In the pharmaceutical industry, ensuring the integrity of the supply chain, material quality, and patient safety is paramount. One of the tools that organizations use to achieve these goals is the audit process. Knowing the […]