SOP Guide for Pharma

Elixir Department: SOP for Line Clearance in Dispensing Area – V 2.0

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Elixir Department: SOP for Line Clearance in Dispensing Area – V 2.0

Standard Operating Procedure for Line Clearance in Dispensing Area

Department Elixir Department
SOP No. SOP/ELX/009/2025
Supersedes SOP/ELX/009/2022
Page No. Page 1 of 8
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To establish a standard procedure for performing line clearance in the dispensing area to ensure that the area is free from any materials, products, documents, or equipment from the previous activity before initiating a new batch dispensing operation.

2. Scope

This SOP is applicable to all dispensing operations carried out in the designated dispensing area of the Elixir Department. It must be followed before the commencement of any new batch or material dispensing activity.

3. Responsibilities

  • Warehouse Operator:
    • Perform preliminary check and inform QA for line clearance.
  • QA Personnel:
    • Conduct line clearance inspection and authorize area readiness.
    • Ensure the area is free from materials/documents related to previous activities.
  • Warehouse Supervisor:
    • Coordinate the line clearance activity and ensure compliance with this SOP.
See also  Elixir Department: SOP for Calibration of Dispensing Balances - V 2.0

4. Accountability

The Head of Quality Assurance is accountable for ensuring that line clearance is conducted as per procedure and documented prior to

any dispensing activity.

5. Procedure

5.1 Pre-Line Clearance Checks

  1. Ensure the area is cleaned and sanitized as per the cleaning SOP.
  2. Verify that all equipment such as weighing balances, scoops, spatulas, and containers are cleaned and labeled “CLEANED.”
  3. Check that no material, label, or document from the previous batch is present in the dispensing area.

5.2 QA Line Clearance

  1. QA officer shall enter the dispensing area and perform the following verifications:
    • Cleanliness of floors, walls, and equipment surfaces
    • Availability of approved BMR and dispensing labels for the new batch
    • Absence of leftover raw materials, empty containers, or printed documents from the previous batch
    • Calibration status of weighing balances
    • Environmental parameters (temperature, RH, differential pressure)
  2. Record all checks in the Line Clearance Checklist (Annexure-1).
  3. If any discrepancy is observed, report immediately to the QA Manager and hold the activity until resolved.
See also  Elixir Department: SOP for Dispensing Active Pharmaceutical Ingredients for Elixirs - V 2.0

5.3 Documentation

  1. Complete the Line Clearance Checklist and affix it to the BMR.
  2. QA personnel shall sign and date the checklist upon successful clearance.
  3. Store the checklist with the batch documentation for future reference.

5.4 Re-Entry After Interruption

  1. In case of power failure, equipment breakdown, or extended interruption during dispensing:
    • Repeat full line clearance before restarting the activity.
    • Record the interruption and re-clearance in the Remarks column of the checklist.

5.5 Line Clearance Frequency

  1. Before the start of any batch dispensing.
  2. After cleaning and sanitization of the dispensing area.
  3. After any interruption, contamination event, or deviation.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • RH: Relative Humidity
See also  Elixir Department: SOP for Handling Rejected Raw Materials During Dispensing - V 2.0

7. Documents

  1. Line Clearance Checklist (Annexure-1)

8. References

  • WHO GMP Guidelines – Production and In-Process Controls
  • 21 CFR Part 211 – Subpart F: Production and Process Controls

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 Checklist

Checklist Item Status (Yes/No) Remarks
Area cleaned and sanitized Yes –
No previous batch material present Yes –
Approved BMR and labels available Yes –
Calibrated weighing balances available Yes –
Environmental parameters within range Yes Temp: 22.5°C, RH: 52%

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial SOP Release New SOP Creation QA Head
13/04/2025 2.0 Enhanced checklist and re-entry requirements Audit Readiness QA Head
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