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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.

  1. Area Clearance in Solid Dosage Manufacturing – Batch to Batch Changeover
  2. Area Clearance in Solid Dosage Manufacturing – Product to Product Changeover
  3. Equipment Clearance Checklist in manufacturing of Solid Dosage Products – Tablets
  4. Equipment Clearance Checklist in manufacturing of Solid Dosage Products – Pellets
  5. Line Clearance Checklist for Packing of Aerosols
  6. Line clearance checklist for Packing of Sterile products
  7. Line clearance checklist in manufacturing of Aerosols
  8. Line clearance checklist in manufacturing of Sterile (Cytotoxic) products
  9. Line clearance checklist in Packing of Solid Dosage Products
  10. Line clearance in Sterile Cytotoxic manufacturing – Vial preparation
  11. Line clearance in Sterile Cytotoxic manufacturing –Filtration and Filling components preparation
  12. Line clearance in Sterile Non-Cytotoxic manufacturing – Component preparation
  13. Line clearance in Sterile Non-Cytotoxic manufacturing – Filtration, Filling and Terminal Sterlisation
  14. Line clearance in Sterile Non-Cytotoxic manufacturing – Manufacturing
  15. Line clearance in Sterile Non-Cytotoxic manufacturing –Visual Inspection and outer Ampoule washing
  16. SOP for Line clearance and Startup clearance during manufacturing and packing operations.
  17. Startup checklist in Manufacturing
  18. Startup checklist in Packing

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