What are contents of change control in pharmaceutical industry ?
Change control form must has at least following content,
- Change Description (Short)
- Reason for change
- Existing, Proposed and Justification of change
- Impact Assessment of the proposed change on existing and new system
- Action plan to the proposed change
- Risk assessment with proposed change
- Regulatory Assessment
- Effectiveness monitoring after change implementation.
- Closure by QA
I am composing SOps about impact assessment. Can you give me some documents about it
Thanks in advance