The CMO’s facility is another important and fairly obvious aspect of assuring that you receive a quality product with on-time delivery. It is the first thing you will probably see after a visit to the conference room during early discussions, but there are important questions to ask, beyond the look of their (most likely) modern, high-efficiency, and high-volume manufacturing center(s).
Ask the CMO to indicate the specifics of the physical location for your operation, and talk about their current utilization of that space. Request a preliminary layout of your operation in that space. Verify that the facility has state-of-the-art, environmentally controlled areas such as ISO Class 7 and ISO Class 8 manufacturing clean rooms and climate-controlled storage rooms.
Additionally, you should ask about plans for production disruptions. The following questions may be helpful in determining if their facility is a good fit for your product.
Have emergency power generators been installed in the event of a power outage?
If some operations are to be performed offshore, have they determined if the foreign supplier has taken the same precautions?
Is the CMO in a flood zone?
If so, have there been occurrences in the past, and what measures have they taken to mitigate future problems?
Again, as a reminder, do not just take the verbal discussions as final proof. Always ask to see documentation.
