Selection and GMP Auditing of Software and Hardware Vendors

October 7, 2019

The Data Integrity Working Group of Rx-360 members has generated an addendum to the previously issued GMP Audit Manual, Data Governance and Data Integrity which provided an approach for GMP auditing and self-assessment of pharmaceutical […]

Managing Critical Vendors

July 26, 2019

Introduction: The manufacture of medical products, drugs and devices is highly regulated all over the world. All aspects of the manufacturing process, from product design to product delivery, require documented procedures. Key points in the […]

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, […]

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. […]

Templates & Tools

GMP Audit Manual – Data Governance and Data Integrity

March 27, 2018

This data integrity audit manual provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories for data integrity and data governance elements. The scope includes the manufacture and testing of […]

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 […]

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 […]