
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

483s and Warning Letters Point to Inadequate Quality Oversight

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

Published: May 15th 2017 | Updated:

Published: July 1st 2020 | Updated: