Process Validation: Process Qualification and Control
Lesson Code: BPU-1112 (PREMIUM LESSON) An overview of the qualification and continuing verification stages of process validation, intended to demonstrate that a biopharmaceutical process is capable of reproducible commercial manufacturing and to provide ongoing assurance that the process remains in a state of control.
- Category: Biopharma Processes and Equipment
Description
After taking this e-Lesson, you will be able to:
- Explain the purpose of process qualification
- State the pre-requisites that must be in place before process qualification can proceed
- Summarize the activities that occur in process qualification
- Explain the purpose of continued process verification
- Describe some of the assessment tools used in continued process verification
- Explain the role of change control in assessing changes to validated processes
- Provide an example of where requalification would be necessary
PRE-REQUISITES:
- Before taking this module you should have already taken the 'Process Design' module (BPU-1111)
