Category: White Papers

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.  [...]
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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 [...]
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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 [...]
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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 [...]
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Quality Elements for Suppliers of Products or Services to GMP Regulated – Spanish Version
Los Elementos de Calidad para los proveedores de productos o servicios que proveen a empresas reguladas por las Buenas Prácticas [...]
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Rx-360 Quality Elements for Suppliers of Products or Services to GMP Regulated Companies
Quality Elements for Suppliers of Products or Services to GMP Regulated Companies outlines the basic GMP elements expected of suppliers [...]
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Cargo Theft in the Pharmaceutical Industry – What Does it Really Cost?
Introduction Most modern pharmaceutical supply chains are complex, global, outsourced, and decentralized. In addition, many supply chains are vulnerable to [...]
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Upstream Supply Chain Mapping
Introduction:  This white paper reviews the present state of how the pharmaceutical industry maps its upstream raw material supply chain [...]
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Upstream Supply Chain Security
Purpose and Scope: This white paper reviews the present state, current challenges, and recommended best practices for several upstream supply [...]
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Counterfeit, Unapproved and Diverted Drugs Threats & Monitoring Process
Introduction and Overview: The distribution and sales of Counterfeit, Unapproved and Diverted Drugs (CUDD) are a global concern for pharmaceutical [...]
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