Change Control system

Generally in all the pharmaceutical industries for every change in the procedure or in the system or in the process, a procedure is in place called change control system. 

• The user department (the department which wants to change any system or procedure or process) sends a request to Quality Assurance department by mentioning brief description about the change in the request.

• The type of change shall be clearly mentioned either it is minor or major or critical.

• For tracking of any change in the organization, Quality Assurance department allots a number for every change.

• After allotting the number, Quality Assurance department will assess the impact on any other systems or documents or process for the change proposed by the user department.

• If the proposed change relates to any other departments, Quality Assurance department identifies those departments. Those department HOD's shall approve / reject the proposed change.

• If the proposed change is approved by all department HOD's, finally it comes to Quality Assurance department for the final approval.

• During the final approval, the HOD of Quality Assurance can approve it or reject it.

• If the change is approved, the user department can change as they mentioned their requirements in the change control.