Elixir Department: SOP for Dispensing of Preservatives for Elixirs – V 2.0

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Elixir Department: SOP for Dispensing of Preservatives for Elixirs – V 2.0

Standard Operating Procedure for Dispensing of Preservatives in Elixir Formulations

Department Elixir Department
SOP No. SOP/ELX/038/2025
Supersedes SOP/ELX/038/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standard procedure for the safe, accurate, and contamination-free dispensing of preservatives used in the manufacturing of oral elixirs. This SOP ensures the correct quantity and handling of preservatives to maintain product stability and microbial control.

2. Scope

This SOP is applicable to all activities related to the dispensing of preservatives such as methylparaben, propylparaben, sodium benzoate, potassium sorbate, and similar agents used in the Elixir Department.

3. Responsibilities

  • Dispensing Operator:
    • Carry out dispensing of preservatives as per batch requirement and record the activity.
  • Supervisor:
    • Verify material identity, batch number, and quantity before and after dispensing.
  • QA Officer:
    • Ensure documentation is complete and approve materials for release to manufacturing.
See also  Elixir Department: SOP for Sampling of Raw Materials for Elixirs - V 2.0

4. Accountability

The Production Head is accountable for implementation and adherence to this SOP and ensuring that preservatives are dispensed accurately and documented properly.

5. Procedure

5.1 Material Verification

  1. Check the Material Requisition Form (MRF) and Batch Manufacturing Record (BMR) for the exact name, quantity, and batch number of the required preservative.
  2. Ensure the container has a green “Approved” status label and is within expiry.
  3. Confirm container integrity and label details:
    • Material Name
    • Batch Number
    • Manufacturing and Expiry Dates

5.2 Dispensing Procedure

  1. Transfer the container to the dispensing booth or laminar airflow (LAF) area.
  2. Clean the container exterior with 70% IPA and dry it before opening.
  3. Use pre-cleaned stainless steel scoops or dispensers for solid preservatives; use calibrated pipettes or measuring cylinders for liquid preservatives.
  4. Weigh the required quantity using a calibrated balance and record the reading.
  5. Seal the original container tightly and label it as “Partially Used – To be Returned”.
See also  Elixir Department: SOP for Dispensing Solvents and Vehicles - V 2.0

5.3 Labeling and Recording

  1. Label the dispensed container with:
    • Material Name
    • Batch Number
    • Quantity Dispensed
    • Date
    • Dispensed By and Verified By
  2. Make entries in the Material Dispensing Log (Annexure-1) and initial the BMR.

5.4 Quality Check and Release

  1. The QA officer shall:
    • Review documentation and physical container.
    • Approve the use of the dispensed preservative by signing the Approval Form.
  2. Release the dispensed material to production upon approval.

5.5 Storage and Return of Excess

  1. Return the unused preservative to the warehouse with a filled Material Return Form.
  2. Store the returned material in designated “Approved – Partially Used” storage with controlled conditions.

6. Abbreviations

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

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Certificate of Analysis (Annexure-2)
  3. Approval and Release Form (Annexure-3)
See also  Elixir Department: SOP for Use of Approved Dispensing Aids and Equipment - V 2.0

8. References

  • 21 CFR Part 211 – Good Manufacturing Practice
  • WHO TRS 986 Annex 2 – GMP Guidelines

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

Date Preservative Batch No. Quantity Dispensed By Verified By
11/04/2025 Sodium Benzoate SB7788 0.500 kg Rajesh Kumar Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Preservative Batch No. Test Result Status
Sodium Benzoate SB7788 Assay 99.5% Complies

Annexure-3: Approval and Release Form

Date Preservative Batch No. Released By Approved By Remarks
11/04/2025 Sodium Benzoate SB7788 Ajay Mehta Manoj Verma Approved for Batch ELX-205

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Issuance New SOP QA Head
11/04/2025 2.0 Updated Procedure and Annexures Standardization and Audit Compliance QA Head
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