Standard Operating Procedure for Line Clearance in Dispensing Areas

Department	Creams
SOP No.	SOP/CRM/018/2025
Supersedes	SOP/CRM/018/2022
Page No.	Page 1 of 5
Issue Date	25/05/2025
Effective Date	30/05/2025
Review Date	25/05/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for line clearance in the dispensing areas. Line clearance ensures that all dispensing equipment and workstations are free of residual materials and contaminants before starting a new dispensing activity. This procedure helps maintain product quality, prevent cross-contamination, and ensure compliance with GMP guidelines.

2. Scope

This SOP applies to the dispensing areas within the Creams Department where raw materials, including active ingredients, excipients, colorants, and preservatives, are dispensed for cream manufacturing. It includes the steps for cleaning, inspection, and verification before beginning new dispensing operations.

3. Responsibilities

• Production Personnel: Responsible for performing line clearance tasks, including cleaning, inspecting equipment, and verifying that the dispensing area is clear of any leftover materials.
• Quality Control (QC): Ensures that line clearance activities are carried out correctly and that all equipment is free from contamination before dispensing new materials. QC also verifies that all documentation is complete.
• Quality Assurance (QA): Oversees the line clearance process, ensuring compliance with this SOP and reviewing the documentation for accuracy and completeness.
• Warehouse Personnel: Ensures that materials are correctly stored and that there is no cross-contamination between different batches of raw materials.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring the proper implementation of the line clearance procedure. The QA Manager is responsible for overseeing compliance with this SOP, reviewing all clearance records, and ensuring corrective actions are implemented as necessary.

5. Procedure

5.1 Pre-Clearance Preparation

1. Review the production schedule to determine which materials need to be dispensed and ensure that the dispensing area is ready for line clearance.
2. Ensure that all materials from the previous batch have been removed from the dispensing area. This includes checking work surfaces, storage areas, and equipment to ensure no residues remain.
3. Ensure that any previous dispensing equipment, such as scales, containers, or mixing tools, is cleaned and sanitized as per the cleaning SOP.
4. Make sure that the area is free from non-production items that could lead to contamination.

5.2 Line Clearance Process

1. Clean and sanitize all dispensing equipment and work surfaces, following the prescribed cleaning procedures. Ensure that all residue from previous materials is removed.
2. Perform a visual inspection of the dispensing area to ensure that there is no residual material, and that the area is free from contamination or foreign objects.
3. Check that all dispensing tools (e.g., scales, measuring devices, containers) are properly calibrated and clean. Ensure that no previous material remains on or in the equipment.
4. Verify that all containers, labels, and other materials are accounted for and correctly labeled for the new batch.

5.3 Documentation of Line Clearance

1. Complete the Line Clearance Log, documenting that the dispensing area has been cleared and is ready for use. This log should include:
   • Area or equipment inspected
   • Personnel responsible for the line clearance
   • Time and date of clearance
   • Any discrepancies or issues encountered during the clearance process
2. The Line Clearance Log must be signed by both the production personnel and the QA representative to verify that the area has been inspected and cleared.
3. If any discrepancies or contamination is found, the affected area must be cleaned again, and corrective actions must be documented in the Corrective Action Report.

5.4 Post-Clearance Activities

1. Once the line clearance process is completed and documented, notify the production team that the area is ready for dispensing new materials.
2. Ensure that all materials required for the new batch are correctly staged and ready for dispensing according to the production schedule.
3. Ensure that any remaining materials from the previous batch are properly segregated and returned to their designated storage areas.

5.5 Handling Discrepancies During Line Clearance

1. If discrepancies or contamination are found during the line clearance process (e.g., leftover materials or incorrect equipment), the line clearance must be repeated.
2. Any significant contamination or failure to properly clear the line must be documented in the Material Discrepancy Report, and corrective actions should be implemented.
3. The QA team must review all discrepancies and determine appropriate corrective actions, which may include retraining of personnel or revision of procedures.

5.6 Final Review and Approval

1. The QA team will review the Line Clearance Log and any discrepancy reports to ensure that the area is properly cleared and ready for the next dispensing activity.
2. Once all line clearance activities are completed, and any issues are resolved, the production team can proceed with the dispensing of new materials.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Line Clearance Log (Annexure-1)
2. Material Discrepancy Report (Annexure-2)
3. Corrective Action Report (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Internal SOP for Cleaning and Equipment Maintenance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Line Clearance Log

Area/Equipment Inspected	Person Responsible	Time/Date	Discrepancies Found	Action Taken
Dispensing Area A	John Doe	25/05/2025	No residues found	Clearance approved

Annexure-2: Material Discrepancy Report

Material Name	Batch Number	Discrepancy Description	Corrective Action Taken	Reported By	Resolution Date
Colorant A	12345	Residue left on scale	Re-cleaned, reviewed procedures	Jane Smith	26/05/2025

Annexure-3: Corrective Action Report

Deviation	Corrective Action Taken	Responsible Person	Completion Date
Residue in Dispensing Area	Revised cleaning protocol, retrained staff	John Doe	27/05/2025

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head