CGMP 4.4 - line clearance

• Perform line clearance before and after production or a long pause
• Ensure it is safe to approach the equipment by adhering to safety SOP to ensure employee safety when handling any equipment and materials
• Disassemble equipment and parts to expose materials that may be present inside
• Check and verify each point on a checklist highlighting the "hard to clear" or "high risk" points based on experience and risk assessment
• Remove any batch documentation (records, labels), materials (starting, packaging, finished products), and rejects from the equipment/line/area
• Update the status of the equipment/line/area