|Supplier audits don't have to be a headache |
if you know how to handle them.
by Ken Christie, COO
VTS Consultants, Inc.
The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However, without adequately planning what needs to be done, how and when to do it, and how issues will be tracked and resolved when found, a supplier audit can easily become a failed exercise.
In this article, I will review the current regulatory expectations for the qualification of suppliers through the use of on-site audits and so-called “paper audits” — for those partners deemed as critical based on the potential impact to the final quality of your product. In addition, I will provide best practices for conducting the various stages of a supplier audit, based on lessons I’ve learned while performing such audits in the biopharma industry over the years.