What To Expect From Your First CMO Remote Audit

Remote quality audits (sometimes called “virtual audits” or “e-audits”) are replacing the in-person quality audits that have long been an integral part of selecting a life science Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO). Choosing the right manufacturing partner means going beyond just technical specs. Having the opportunity to see facility layouts and condition are critical. However, with COVID-19 changing how we think about travel, will the in-person audit become a thing of the past? The FDA has issued an extension and expansion of temporary Medical Device Single Audit Programs (MDSAP). This extension is currently limited to where “travel restrictions or social/physical distancing as a result of the pandemic prevent on site audits from occurring.” With social distancing looking to be required over the next half-year or more, there is the possibility the extension could become permanent. However, GMP does not require on-site audits and the benefits offered by touring online could spell the end of CMO facility visits for good. Now is the time to begin familiarizing yourself with the remote audit process.