Design Qualification from the FDA's Perspective

Is there a concrete requirement of the FDA for a Design Qualification (DQ)? The answer is (actually) No. There is a requirement in 21 CFR 211.63 for an appropriate design, but no explicit requirement for a DQ. In the old Process Validation Guideline from 1987, there was no Design Qualification. In the new Process Validation Guidance from 2011 the term Design Qualification does not exist either. However, there is a part that demands "Verifying that utility systems and equipment are built and installed in compliance with the design specifications (e.g., built as designed with proper materials, capacity, and functions, and properly connected and calibrated". So, at least a design specification is required - and the FDA makes this clear.

The relevance of a "design consideration" becomes relatively clear when taking a look at a current FDA Warning Letter. With reference to 21 CFR 211.63 the FDA criticizes several design deficiencies, but also maintenance deficits. Criticized were downtimes, missing maintenance and leakages, with the danger of biofilms. The FDA did not like the company's answer that they had not paid attention to monitoring during the design of the plant. In addition to repairing the leakages, the FDA also demanded a scientifically based maintenance programme and a plan to change the design deficiencies.

Conclusion: Design considerations also play a role for the FDA, although DQ is not explicitly required.

For more details please see the FDA's Warning Letter to Kumar Organic Products Limited.