Guide to Investigations – A Collaborative Publication by the Rx-360 Latin America Working Group
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.
Cargo Security Risk Assessment and Planning for Global Operations
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 Announces Approval as a Pilot Center of Excellence for the APEC Regulatory Harmonization Steering Committee
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.
Supplier Assessment Questionnaire
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 Announces 2024 Board of Directors
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 Releases Two New Publications in Support of the Pharmaceutical Industry and Patient Safety
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.
Managing Critical Vendors Version 2.0
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 […]
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 […]
Working Group Excerpts
Improve Supply Chain Security: An Overview of Our Supplier-Led Working Group’s Whitepapers
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 […]