Publications

Rx-360 Remote Audit Best Practice Guide

August 28, 2020

Rx-360 through our Member Consortium has developed a Version 1.0 Best Practice Guide for Remote Auditing. This initial version will present a foundation on best practices that the Rx-360 membership have utilized and observed as […]

Publications

Rx-360 Supply Chain Security: Audits and Assessments of Third-Party Warehousing and Distribution Facilities Version 2.0

April 27, 2020

Pharmaceutical manufacturers and distributors frequently outsource various business functions to organizations that have a specialized expertise. While outsourcing can offer improved efficiency and cost savings, it also creates certain risks to product safety and security […]

Publications

Rx-360 Technical Paper on Tamper-Evidence and First Opening Indication

April 7, 2020

The practice of tampering and re-use of original packaging represents a significant threat in the overall landscape of counterfeit and illicit drugs. A problem, which is growing and threatens the global pharmaceutical supply chain as […]

Publications

Rx-360 Supply Chain Security: Prevention of Re-use of Genuine Packaging Components for Counterfeit Products

January 29, 2020

Counterfeit medicines are a serious and growing problem. Some estimates indicate that the global trade in counterfeit drugs approaches $200 billion per year. Globalization and the rise of eCommerce and B2B websites help to facilitate […]

Publications

Rx-360 Supply Chain Security: A Comprehensive Supply Chain Security Management System Version 2.0

November 7, 2019

Protecting patients is the obligation of the pharmaceutical industry and is fundamental to our business. Supply Chain Security (SCS) is the prevention, detection, and response to intentional adulteration, theft, counterfeit, and diversion that threaten patient […]

Publications

Managing Critical Vendors

July 26, 2019

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 […]

Publications

Rx-360 Natural Disaster Contingency Planning

October 29, 2018

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 […]

Publications

Transition of ISO 13485 2003 to 2016

August 21, 2018

ISO 13485 is an internationally recognized quality management standard for organizations involved in the development, manufacture and distribution of medical devices. The standard was first published in 1996.  It was updated in 2003 and again […]

Publications

Taking a Collaborative Approach to Secure Donated Medicines

June 27, 2018

Providing and receiving donated medicines to populations in need through NGO partners can serve as a tremendous benefit to patients who may not otherwise be able to receive them by way of conventional means.   Unfortunately, […]

Publications

Integrating a Third Party Audit Provider into an Existing Supplier Quality Management Process

December 5, 2017

The increase in requirements and expectations from both Regulators and Customers has challenged the Pharmaceutical Industry to maintain sufficient oversite of their Supplier Management Programs. Suppliers as well are being asked to host more customer […]