Image Repair Must Get to the Root Cause

Abstract

Consider the recent discovery of nitrosamines in a third classification of drugs (4) and the suspected manipulation of product testing data used in the development of a gene therapy's manufacturing process (5). A quality culture should be adopted throughout an organization, said Patrizia Cavazzoni, deputy director of operations at FDA's Center for Drug Evaluation and Research, at the September 2019 PDA/FDA Joint Regulatory Conference. Executive management is ultimately responsible for assuring reliable manufacturing operations and high-quality standards, Cavazzoni said, noting that warning letters are directed to the top company executive to emphasis the importance of quality throughout the organization (6).