CMO Data Review


Wanted to see if someone can elaborate on QC data review and mfg batch record review for both commercial and clinical IF lots are manufactured at a qualified CMO (with appropriate quality systems and QC and QA units)? Basically, the data is reviewed by the qualified CMO QC, QA and Mfg units. Since assurance of product quality is the ultimate responsibility of the drug manufacturer/NDA holder, other than routine oversight, is data/batch record review required by the manufacturer/NDA holder in addition to the CMO review?


At a previous position that is all we did! We were a “virtual” QC/QA department reviewing all the data from our manufacturers. This company is currently in Phases 2 & 3 with their products, and our virtual Q department was made of 7 people total, including a document control specialist. Although it is somewhat on the gray zone, this is a requirement. In my experience, there were quite a lot of errors on our CMO’s COAs and even calculation errors in the data. The review does not have to be too in-depth, just check 1 calculation per test, and give ensure that the batch record contains all the requirements. If your company is in phase 1 or early 2, you may be able to just do a very superficial review, hire one person to review COA’s and analytical data, and another person to review the BR and manufacturing issues.