New Warning Letter - Quality Oversight in the Focus

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The U.S. Food and Drug Administration FDA keeps on issuing new Warning Letters. More and more Warning Letters are now focusing on inadequate Quality Oversight.

Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also concentrating on the role of the Quality Unit and Quality Oversight. The number of pharmaceutical companies that have received FDA 483s and Warning Letters indicates that quality and management oversight of current good manufacturing practice (cGMP) compliance is a significant and continuing problem in the industry.

In a recent Warning Letter to a Chinese drug manufacturing facility, the FDA investigator observed several examples for inadequate oversight in the following areas:

• Testing of drug products and review of the results
• Qualification of contract laboratory
• Cleaning validation
• Compliance with written procedures for sampling, testing and data review
• Tracking of components used to manufacture drug products
• OOS result investigation

Even more the overview was lost during the transfer of manufacturing documentation and drug product samples. These were lost immediately.

Aside from being the thesis of major FDA enforcement actions, compliance to GMP regulations is, in fact, a part of normal pharmaceutical business that requires diligent management oversight. Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and consider possible problems early enough.

To find out more please also see the the FDA Warning Letter to Bingbing Pharmaceutical.