SOP for Process Change Control in Pharmaceuticals
A formal system by which qualified persons or Subject SOP for Process Change Control in Pharmaceuticals matter Expert of different departments review proposed or actual changes that might affect a validated status of facilities, system, equipment, Document or processes.
SCOPE:-
This procedure is to be followed while controlling process change in Pharmaceuticals Plant.
OBJECTIVE:-
To control process variability
To operate the process smoothly.
RESPONSIBILITY:-
Plant Manager
Quality Control Manager
Quality Assurance Manager
Inventory Control Manager
Production Manager
Maintenance Incharge
Critical Process:
Following are the critical processes in which change need control in order to control Process variability & for smooth operation:
Change of...