Warning Letter for Aurolife demonstrates failures in process validation

The FDA commented in a Warning Letter to Aurolife Pharma that the manufacturer lacked data showing that the process was in “state of control” before batch release. The 483 pointed to the FDA’s guidance document Process Validation: General Principles and Practices, and found the company lacks a state of control of the process, which comes back to change control.

They also found major deficiencies in their OOS and cleaning programs.

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