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)