Line clearance in the pharmaceutical industry is a critical process that ensures a production line is free from contaminants, previous product residues, and unauthorized materials before starting a new batch or product. It helps maintain Good Manufacturing Practices (GMP) and prevents cross-contamination.
A typical Line Clearance Checklist involves:
Removing previous product residues – Cleaning machines, tools, and work areas.
Checking materials & labels – Ensuring only approved materials are present.
Inspecting equipment setup – Verifying calibration and operational readiness.
Confirming personnel readiness – Proper gowning and hygiene compliance.
Approving documentation – Line clearance checklists and records.
- Area Clearance in Solid Dosage Manufacturing – Batch to Batch Changeover
- Area Clearance in Solid Dosage Manufacturing – Product to Product Changeover
- Equipment Clearance Checklist in manufacturing of Solid Dosage Products – Tablets
- Equipment Clearance Checklist in manufacturing of Solid Dosage Products – Pellets
- Line Clearance Checklist for Packing of Aerosols
- Line clearance checklist for Packing of Sterile products
- Line clearance checklist in manufacturing of Aerosols
- Line clearance checklist in manufacturing of Sterile (Cytotoxic) products
- Line clearance checklist in Packing of Solid Dosage Products
- Line clearance in Sterile Cytotoxic manufacturing – Vial preparation
- Line clearance in Sterile Cytotoxic manufacturing –Filtration and Filling components preparation
- Line clearance in Sterile Non-Cytotoxic manufacturing – Component preparation
- Line clearance in Sterile Non-Cytotoxic manufacturing – Filtration, Filling and Terminal Sterlisation
- Line clearance in Sterile Non-Cytotoxic manufacturing – Manufacturing
- Line clearance in Sterile Non-Cytotoxic manufacturing –Visual Inspection and outer Ampoule washing
- SOP for Line clearance and Startup clearance during manufacturing and packing operations.
- Startup checklist in Manufacturing
- Startup checklist in Packing
