Qualification does not replace Validation

In the past, some companies considered qualification to be sufficient and did not carry out prospective process validation. A recent Warning Letter from the FDA highlights the consequences of this approach.

A drug manufacturer received a 483 inspection report from the FDA. The FDA criticised the response letter written by the inspected company and the subsequent correspondence. In general, the FDA lacks supporting documentation on the corrective actions that are supposed to bring the company into compliance.

In particular, the FDA criticised the lack of process validation (21 CFR 211.100). Process validation studies and a process validation report could not be presented during the inspection.

The response from the inspected company included an unimplemented validation master plan and completed installation and functional qualifications.

This was not enough for the FDA. It criticised the fact that the validation master plan did not include active ingredients and that the IQ and OQ data were not suitable for evaluating critical control parameters. It also noted the absence of process validation as indicated by a Process Performance protocol. It expressly refers here to its 'Guidance for Industry on Process Validation'.  

Specifically, the FDA requires:

• A detailed summary of the validation programme to ensure the 'state of control' throughout the entire product life cycle
• A description of the programme for 'Process Performance Qualification'
• The programme for 'Continued Process Verification'
• A timetable for performing appropriate 'Process Performance Qualification' for each marketed medicinal product
• Protocols for 'Process Performance Qualification' 
• A programme and written procedures for the qualification of equipment and facilities.

As is often the case with significant deficiencies, the FDA recommends involving a GMP consultant in this case as well. The consultant's qualifications should comply with 21 CFR 211.34. However, as the FDA also points out in its Warning Letter, senior management remains responsible.

Conclusion: A lack of process validation cannot be replaced by a validation master plan and installation and functional qualification!

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

Are you interested in equipment qualification? The ECA offers online their annually Equipment Qualification Forum at 18/19 November 2025. Speakers from an EU authority and from the Pharmaceutical Industry explain what is state of the art in equipment qualification and how to lean qualification activities (AI, Fleet Management...).