Poor cGMP conditions at a manufacturing facility can ultimately pose a life-threatening health risk to patients. Current regulatory thinking on contamination control requires a holistic approach by evaluating a myriad of contamination sources from facility design to product release.
Contamination risk is often assessed individually but the holistic approach requires assessing risk across multiple variables. This risk assessment should be conducted using thorough technical and process knowledge while adhering to relevant regulations, standards and guidances and meeting current GMPs.
In this presentation, risk in the following areas will be highlighted using case studies and regulator’s observations; gaps that led to contamination issues will be discussed. Using these case studies practical corrective actions will be examined.
- Cleanroom and barrier system flaws that lead to contamination events
- Equipment contamination issues-understand the gaps
- Human borne contamination due to gown choice and management
- Process related contamination
- Myths related to disinfection and cleaning
- Common errors in environmental monitoring
- Common causes of release testing failures