Process Validation - FDA criticises Missing Lifecycle

In a Warning Letter recently published, the FDA addressed deficiencies regarding process validation. What did the FDA discover?

Although the manufacturing process of a product was validated, the FDA criticized that nine batches exceeded the validated size. In addition, the company was criticized for not following its own process validation procedure for validating major changes.

Response of the company to the FDA Warning Letter

In its response to the Warning Letter, the company mentioned that they had retrospectively validated batch sizes and were working on standardised order sizes. The FDA criticized this response due to the missing:

  • Process Performance Qualification Plan
  • Details on the programme describing the maintenance of the validated process.
  • Schedule showing when all actions have been completed.

Due to those missing elements, the FDA was unable to assess the adequacy of the responses.

The FDA also indicates in the Warning Letter that process validation is a lifecycle process that begins with development and must be considered further in the routine. The Process Performance Qualification then shows that the process is initially "in control". According to the FDA (referring to its Process Validation Guidance), it is followed by an accompanying oversight during routine production to show the stability of the process (Continued/Ongoing Process Verification).

Conclusion: As part of its inspections, the FDA checks meanwhile whether process validation has been implemented as a life cycle model.

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

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