Late Stage Development
The data gathered from the manufacturing of the early phase lots is summarized in a report. This report serves as the basis for the product’s late stage development activities also referred to as pre-Process Validation activities.
These pre-Process Validation activities can be divided as follows:
- Risk Assessment, where the critical parameters are identified and rated using an internal system in order to determine if further process evaluation and experiments are required.
- Hold Time Studies, typically performed on a lot before starting Process Validation in order to determine the shelf life of key intermediates.
- Operational Range finding studies and Design of Experiments (DOE’s), are performed as part of the late stage development and before the process validation activities.
The activities above are performed in order to reach the necessary operational parameters that will minimize the risk of failure during process validation and commercial manufacturing.
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