Process Validation
Collect and evaluate data from the process design stage to production, which are used to generate the scientific evidence that the process consistently produce high quality products. Process validation involves a series of activities that occur during the product life cycle and production.
Process validation activities are generally described in three phases
-
Phase 1―Process Design
-
Industrial production processes are identified based on knowledge gained from development and scale-up activities.
-
Phase 2―Process Performance Qualification
-
The designed processes are validated to demonstrate their repeatability for commercial production.
-
Phase 3―Continuous Process Verification
-
The controlled state of the process is continuously guaranteed in the daily production
Cleaning Validation
The cleaning procedure for the equipment, systems, or utilities which are in direct contact with products should be validated and documented, to ensure active ingredients and potential residues from previous batches, and/or potential microbial contamination are removed and controlled in an acceptable level that could avoid the adverse effect on the safety and quality of the following manufacturing batch.
Packaging Validation
Package types are validated in the minimum and maximum range for mechanical setting to define the key component parameters or other factors such as temperature, mechanical speed, sealing pressure, etc.
