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 […]


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 […]


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, […]


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 […]


Quality Elements for Suppliers of Products or Services to GMP Regulated – Spanish Version

December 4, 2017

Los Elementos de Calidad para los proveedores de productos o servicios que proveen a empresas reguladas por las Buenas Prácticas de Fabricación (BPF); describen los elementos básicos de las buenas prácticas de fabricación (BPF) que […]


Rx-360 Quality Elements for Suppliers of Products or Services to GMP Regulated Companies

October 2, 2017

Quality Elements for Suppliers of Products or Services to GMP Regulated Companies outlines the basic GMP elements expected of suppliers whose products or services eventually enter the supply chain for commercial manufacturing and delivery of […]


Cargo Theft in the Pharmaceutical Industry – What Does it Really Cost?

January 17, 2017

Introduction Most modern pharmaceutical supply chains are complex, global, outsourced, and decentralized. In addition, many supply chains are vulnerable to security risks, ranging from thefts to malicious product tampering. Successful security professionals articulate and prove […]


Upstream Supply Chain Mapping

April 18, 2016

Introduction:  This white paper reviews the present state of how the pharmaceutical industry maps its upstream raw material supply chain and the associated challenges that accompany it. Specifically, this paper aims to cover the following: […]