Templates & Tools

Supplier Assessment Questionnaire

January 19, 2021

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 […]

Remote Auditing Technology Best Practices and Solutions

January 11, 2021

Auditing to verify a process or system meet stated criteria.  The audit process involves looking for objective evidence that will substantiate that the process or system under review meets the objectives of the quality management […]

Remote Auditing – A Supplier Perspective

December 8, 2020

Although remote auditing has been in existence for quite a while the practice has become more prevalent and expanded with the recent onset of COVID-19. With public health or other emergencies that could cause risk […]

Rx-360 Technical Visit Guidelines for the Regulated Medical Product Industry Upstream Supply Chain

October 27, 2020

Supplier qualification audits and supplier technical visits are part of routine operations when working in the pharmaceutical or biotech industry.  Many times, technical visits and audits are confused with one another because there is some […]

Rx-360 Supply Chain Security White Paper: Incident Management Version 2.0

The threats of intentional adulteration, cargo theft, counterfeiting, illegal diversion, and tampering are a serious problem in our global marketplace; where criminals are profiting by putting unassuming patients at risk. These threats are product integrity […]

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 […]

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 […]

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 […]

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 […]