CRLs Should List the Third Party Manufacturer

It probably is good for the public interest, and frankly for the manufacturing ecosystem, for the FDA to be directed (and given the authority) to disclose the third party whose “facility-related deficiencies” identified during a Current Good Manufacturing Practices (cGMP) results in a CRL.

A little public shaming would probably help deal with widespread structural deficiencies amongst CDMOs.

Something certainly needs to happen, this is happening way to often.

Photo by Leah Newhouse on Pexels.com

Embarrassing Photos

This photo is on the embarrassing side.

Messy Moderna binders from https://hbr.org/podcast/2020/11/remote-feedback

If I stumbled across this on a gemba walk there would be coaching on proper storage techniques of documents. My only hope is some corporate communications person made it this way on purpose and the poor person in the photo was muttering under their breath the entire time.

There is an opportunity here on connecting with communications team on best ways to showcase GxP activities. I recommend writing a good policy on the subject and ensuring it is appropriately bought into.