Rx-360, an International Pharmaceutical Supply Chain Consortium has created this Natural Disaster Contingency Planning guideline in response to natural disasters our members are experiencing. This guideline can serve as a baseline to assist in proactively considering how your organization would internally react in the unfortunate circumstance that a natural disaster impacts one of your business locations.

Supplier qualification audits and supplier technical visits are part of routine operations when working in the pharmaceutical or biotech industry.  Many times, technical visits and audits are confused with one another because there is some […]

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 […]

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 […]

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 […]