Standard Operating Procedure (SOP) for Line Clearance in the Pharmaceutical Industry

Document Details

• SOP Number:  PT/004
• Effective Date: MAY.2024
• Review Date: NOV.2024
• Version Number: Version 8.0
• Prepared by: Naveen kumar
• Approved by:Srikanth

1. Objective

To establish a standardized procedure for conducting line clearance in manufacturing and packaging areas to ensure product integrity and avoid cross-contamination or mix-ups.

2. Scope

This SOP is applicable to all manufacturing and packaging operations within the pharmaceutical production facility.

3. Responsibility

3.1 Production Personnel

• Ensure the line is cleared and ready before initiating operations.
• Conduct preliminary checks and remove leftover materials or components.

3.2 Quality Assurance (QA) Personnel

• Verify the line clearance activities performed by the production team.
• Provide final approval for starting operations after thorough checks.

4. Definitions

4.1 Line Clearance

The process of ensuring that a manufacturing or packaging line is free of any previous product, components, or documentation and is ready for the next operation.

4.2 Type-A Clearance

Line clearance performed between batches of the same product. Focuses on removing leftover materials from the previous batch.

4.3 Type-B Clearance

Line clearance performed between different products. Includes a thorough cleaning and removal of all product-related materials, components, and labels to prevent cross-contamination.

5. Procedure

5.1 General Instructions

1. Ensure that the required cleaning tools, checklists, and documents are available
2. Follow the respective checklist for Type-A or Type-B clearance.

5.2 Type-A Line Clearance Procedure

1. Remove all leftover materials, components, and product residues from the area.
2. Check that no labels, packaging materials, or documentation from the previous batch remain.
3. Ensure that all equipment used in the previous batch has been cleaned and verified.
4. Document the clearance process using the “Type-A Clearance Checklist.”
5. QA personnel verify and approve the clearance.

5.3 Type-B Line Clearance Procedure

1. Perform a complete removal of all materials, components, and labels from the previous product.
2. Clean all equipment, surfaces, and tools as per the cleaning procedure for product changeover.
3. Verify that the area is free from any visual residue or contamination.
4. Inspect all documentation to ensure no records from the previous product remain.
5. Complete and document the “Type-B Clearance Checklist.”
6. QA personnel perform a final check and approve the clearance before starting the next product’s operations.

6. Documentation

• Type-A Clearance Checklist: Document line clearance activities between batches of the same product.
• Type-B Clearance Checklist: Record thorough clearance activities between different product

7. Precautions

1. Always follow the cleaning and clearance checklist meticulously to avoid errors.
2. Use appropriate personal protective equipment (PPE) during clearance activities.
3. Ensure proper disposal of waste materials as per waste management protocols.

8. Training

All personnel involved in line clearance activities must undergo training on this SOP and associated checklists.

1. [Internal SOPs/Guidelines]
2. [Regulatory Requirements, e.g., WHO GMP, USFDA, or EU GMP]
3. [Equipment Cleaning SOPs]