Consider using simulation studies to conduct drug product operational qualification
4
Write it all down in a validation master plan focused on your cold chain processes
Clearly define all your risks up front
Understand environmental hazard challenges other than temperature and how they could affect biosimilarity after interactions with the primary container
Understand interactions between multiple hazards
How do these interactions impact drug product quality
Temperature and shock/vibration to particulate formation
Shock/vibration and pressure to CCI and sterility
Consider using simulation studies to conduct drug product operational qualification
Controlled versus uncontrolled environment
Full range of testing hazards in your ‘design space’
Write it all down in a validation master plan focused on your cold chain processes
Execute a risk assessment and prepare a mitigation plan for your biosimilar cold chain
Clearly identify hazards other than temperature
Justify your approach for operational qualification and performance qualification
