So, the idea of traveling domestically here in the US to perform your supplier/vendor audits is still a questionable practice. The fact is that although some companies are opening up the allow site visits, the vast majority are still refusing entry to their facilities and most of the staff that handle audits are working remotely themselves.
This could be extremely disruptive if you are expecting to keep your clinical or commercial manufacturing on track.
Now, add in the dependency upon foreign manufacturers and their overseas facilities as CDMO’s for many clinical manufacturing programs, and you amplify the magnitude of the problem, especially for API products. This is the state of play for the majority of the leading companies in the industry.
With these conditions in play then, it is in imperative that you have a reliable virtual auditing program to offset the disruption that has been caused by the pandemic.
Using our protocol, which we first implemented early in February 2020, we now have a database of some forty such audits completed and using that approach we believe we can guarantee greater than 90% the accuracy of a conventional in person audit.
This represents a significant win in terms of delivery and efficiency and perhaps sets up the possibility of more frequent interactions with the supplier’s site as a result of the success of technology and our protocol. This is a great unexpected benefit/win for compliance.
The lesson here is one of a successful pivot through out-of-the-box thinking at the time of adversity.
If you’d like to know more, or help with your virtual auditing, contact us, or better yet book a free consult.
See you on the inside.
Contact us if you would like to know more….610-422-1097.