Elixir Department: SOP for Double Check System During Material Dispensing – V 2.0

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Elixir Department: SOP for Double Check System During Material Dispensing – V 2.0

Standard Operating Procedure for Double Check System During Dispensing of Materials

Department Elixir Department
SOP No. SOP/ELX/037/2025
Supersedes SOP/ELX/037/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

This SOP establishes the procedure for implementing a Double Check System during the dispensing of raw materials, excipients, and solvents in the Elixir Department. It ensures that dispensing is carried out with full accuracy, traceability, and regulatory compliance, reducing the risk of human error.

2. Scope

This SOP applies to all materials dispensed for elixir manufacturing processes and must be followed by the designated dispensing operator and verifying personnel involved in material handling and weighing.

3. Responsibilities

  • Dispensing Operator:
    • Perform the initial dispensing activity and fill out the required documentation.
    • Ensure readiness for second-person verification.
  • Second Verifier (Supervisor or Authorized Personnel):
    • Verify material name, batch number, weight, container label, and documentation entries.
    • Sign the verification section on the dispensing log and BMR.
  • QA Officer:
    • Periodically audit double check entries and approve completeness of documentation.
See also  Elixir Department: SOP for Material Movement Record Maintenance - V 2.0

4. Accountability

The Production Head is accountable for

enforcing this SOP and ensuring that no material is released for manufacturing without completion of double verification during dispensing.

5. Procedure

5.1 Preparation Before Dispensing

  1. Ensure the dispensing booth, balance, and accessories are clean and calibrated.
  2. Verify the approved status of the raw material and confirm storage conditions.
  3. Prepare dispensing logbook and relevant BMR page for real-time entry and signature.

5.2 First-Person Activity

  1. The dispensing operator shall:
    • Identify the material and verify label details.
    • Weigh the material as per the batch requirement.
    • Record the following:
      • Material Name
      • Batch Number
      • Weighed Quantity
      • Date
      • Sign and mention time of activity

5.3 Second-Person Verification

  1. The verifier shall:
    • Cross-check the material label against the entry in the dispensing log.
    • Verify the actual weight using the same calibrated balance.
    • Ensure the container has been sealed and labeled properly after dispensing.
    • Sign the double check section of the dispensing log and mark date/time of verification.
See also  Elixir Department: SOP for Segregation of Quarantined and Approved Materials - V 2.0

5.4 Documentation and Labeling

  1. Affix “Double Checked” status label on each dispensed container with initials of both personnel.
  2. All entries in the dispensing log must be verified before transferring material to production.

5.5 Exception Handling

  1. If a discrepancy is found during verification:
    • Stop further processing and inform QA immediately.
    • Document the deviation using the standard Deviation Form.
    • Retain the material in a segregated area until disposition is authorized.

6. Abbreviations

  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • SOP: Standard Operating Procedure

7. Documents

  1. Material Dispensing Log with Verification Section (Annexure-1)
  2. Double Checked Container Label Format (Annexure-2)
  3. Deviation Reporting Form (Annexure-3)

8. References

  • WHO GMP Guidelines – Pharmaceutical Production
  • 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals
See also  Elixir Department: SOP for Cleaning of Dispensing Area Before and After Use - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log with Verification Section

Date Material Batch No. Qty Dispensed Dispensed By Verified By Remarks
11/04/2025 Sodium Citrate SC5599 2.5 kg Rajesh Kumar Sunita Reddy Verified OK

Annexure-2: Double Checked Container Label

Material Name Batch No. Qty Dispensed By Verified By Date
Sodium Citrate SC5599 2.5 kg RK SR 11/04/2025

Annexure-3: Deviation Reporting Form

Date Material Batch No. Deviation Observed Corrective Action QA Approval
11/04/2025 Sodium Citrate SC5599 Label mismatch Corrected and reverified Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP QA Head
11/04/2025 2.0 Inclusion of Label Format and Annexures GMP Update QA Head
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