A good rule of thumb for sponsor audits is to conduct one-to-two per year, usually when you first begin working with a CDMO and then about half way through a project. Unless you have a QA specialist in house that can be freed up, it’s a good idea to hire an experienced consultant to conduct the audits for you. In terms of the planning, it’s important to give your CDMO a few weeks’ notice before arriving for an audit so that the appropriate professionals will be available to address your questions and host you through an inspection tour.
In addition to these general guidelines for conducting a sponsor audit, below are eight considerations to think about before conducting your audit:
Following these steps should help you learn a lot of what you need to know about your CDMO and its operations. But, sometimes there are also warning signs that can guide you as well. If the CDMO does not allow you in certain areas, if it prohibits you from speaking to certain employees, if it’s reluctant to share certain documents, you have the right to be suspicious. A good CDMO should be an open book with nothing to hide.
This article is the third in a series of articles on audits in API manufacturing. For additional insights, please read: Paving the Way for a Smooth FDA Inspections; and Internal Auditing – The Belt and Suspenders Approach to Quality in API Manufacturing.