FDA criticises Non-Application of SPC (Statistical Process Control) in Validation

In 2011, the FDA introduced updated guidance on process validation, establishing a life cycle that includes Continued Process Verification (CPV) to assess whether processes remain validated. Many companies use Statistical Process Control (SPC) to demonstrate the "state of control" during this stage.

The FDA recently issued a Warning Letter to EyePoint Pharmaceuticals, Inc., criticizing their SPC practices due to a lack of control charts. Although the company intended to use SPC for CPV, the FDA noted that their methods were unspecified and that manufacturing departments had failed to create control charts as required by internal procedures.

During the FDA inspection, four previously undetected trends were discovered, highlighting SPC's importance. EyePoint acknowledged this issue and committed to following internal SPC protocols. Additionally, the FDA emphasized the need for a scientific approach to process validation, citing insufficient rigor in sampling methods during validation runs.