Consultants: A Universal Remedy for GMP Deficiencies?

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The question in the title "Are consultants a universal remedy?" is of course a bit provocative. Yet the sole involvement of a consultant following a 483 deficiency report from the FDA is often insufficient. Why?

This much up front: The FDA often recommends in its Warning Letters the involvement of a consultant who gives support in addressing deficiencies identified in the Warning Letter. A hand disinfectant manufacturer also relied on this recommendation.

What is the background?

In the case of this manufacturer of hand disinfectants, the FDA criticized, among other things, "Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22)." There was a lack of specifications and appropriate personnel for "oversight" of the manufacturing process.

There were no procedures for deviations, corrective and preventive actions (CAPAs), change control, recalls, supplier qualification, equipment cleaning, and water system monitoring. In addition, there were releases of starting materials without identity testing and final product releases without appropriate release testing.

The company informed the FDA that it was currently working on developing and implementing a quality management system and had brought in a consultant. What the FDA did not receive, however, were further details such as timelines and action plans.

In the Warning Letter, the FDA again explicitly recommends the involvement of a consultant. However, the responsibility for solving the deficiencies and CGMP compliance remains with the upper management, despite the involvement of a consultant.

Conclusion: In responses to FDA inspection deficiencies, vague statements such as "we are currently in the process of solving the problem with the help of a consultant" are not sufficient. The FDA expects clear timelines and specific action plans.  

You can find the complete Warning Letter on the FDA website.