'The cost of quality' is a simple statement and yet few companies in the pharmaceutical manufacturing industry are paying close enough attention to this concept.
Corporate focus is, for the most part, focused on compliance and meeting regulatory requirements to sell products across the globe. Those compliance regulations require companies to perform at a prescribed level and maintain certain required systems.
Some of those quality systems include familiar functions such as incoming inspections, preventative maintenance and calibrations, as well as complaints, returns, recalls, inspections and corrective and preventative action (CAPA) teams.
Isolation of aseptic processes is not a new technology. Rigid stainless-steel isolators have been available...