Publications

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 […]

Templates & Tools

Guide: Best Practices for Quality Agreements Version 2.0

April 17, 2018

Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply chain. Especially in regulated environments, QAs form a crucial part of the supplier qualification process. […]

Publications

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 […]

Publications

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 […]