Rx-360 Remote Audit Best Practice Guide
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 […]
Rx-360 Supply Chain Security: Audits and Assessments of Third-Party Warehousing and Distribution Facilities Version 2.0
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 […]
Rx-360 Technical Paper on Tamper-Evidence and First Opening Indication
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 […]
Rx-360 Supply Chain Security: Prevention of Re-use of Genuine Packaging Components for Counterfeit Products
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 […]
Rx-360 Supply Chain Security: A Comprehensive Supply Chain Security Management System Version 2.0
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 […]
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 […]
Transition of ISO 13485 2003 to 2016
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 […]
Taking a Collaborative Approach to Secure Donated Medicines
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, […]
Integrating a Third Party Audit Provider into an Existing Supplier Quality Management Process
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 […]