Drugmakers and medical device firms should expect at least 10% of their suppliers are “virtual companies,” often with only a single administrative office or just a post office box being their only tangible existence, said John Avellanet, founder and principal consultant at Cerulean Associates LLC. His comments came at FDAnews’ Supplier Quality Management Congress in Bethesda, Maryland.
The first challenge is figuring out which supplier is a virtual company; few virtual suppliers hang out a sign saying “virtual company.”
Virtual companies also present auditing challenges because they have no material production sites of their own to inspect as they contract out services to others. Virtual suppliers that are service providers, such as calibration companies, may be set up in a converted home garage. And increasingly, consultants and other professional services operate out of home offices.
One approach to qualify virtual suppliers is to beef up incoming acceptance activities accompanied by remote audits involving teleconference interviews with pertinent personnel, Avellanet said.
Regular analyses of data provided by the supplier are also recommended to ensure product quality consistency, he added.
And drug and device companies working with virtual suppliers should become familiar with ISO 19011:2011 Guidelines for Auditing Management Systems, which covers remote auditing.
Adapted for web from original August 2012 publication in the “Washington Drug Letter”