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 […]
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 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
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?
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
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: […]
Upstream Supply Chain Security
Purpose and Scope: This white paper reviews the present state, current challenges, and recommended best practices for several upstream supply chain security topics. The “upstream supply chain” refers to any part of the supply chain […]
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 patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine […]