COMMISSIONING: An Opportunity to Test, Challenge, and Improve the System Prior to Qualification

Commissioning gives biopharmaceutical companies the opportunity to work out the kinks in their equipment prior to qualification for GMP activities.  However, companies make the mistake of skipping the commissioning phase.  After vendor startup of equipment or after a minimum of air test and balance and room walkthroughs for a facility, companies head straight into qualification without analyzing true functionality, usability, …