Scientific Justification for Monitoring Indirect Product Contact Surfaces
With comprehensive regulatory guidelines around cleaning monitoring requirements for direct product contact surfaces. The industry has seen a gap for indirect product cleaning validation monitoring requirements.
2019-11-04
Key Takeaways:
- Indirect surfaces can transfer residues and must be assessed for contamination.
- Regulatory clarity exists for direct surfaces but is lacking for indirect ones.
- Walkthroughs and visual analysis help justify monitoring for indirect surfaces.
- 86% of 35 pharma manufacturers vary monitoring requirements by surface type.
- Monitoring should match surface criticality and proximity to the product stream.
