Elixir Department: SOP for Dispensing Excipients for Oral Liquid Formulations – V 2.0

Posted on By

Elixir Department: SOP for Dispensing Excipients for Oral Liquid Formulations – V 2.0

Standard Operating Procedure for Dispensing Excipients in Oral Liquid Elixirs

Department Elixir Department
SOP No. SOP/ELX/028/2025
Supersedes SOP/ELX/028/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

The purpose of this SOP is to describe the procedure for accurate and contamination-free dispensing of excipients used in oral liquid elixir formulations. The procedure ensures consistency, traceability, and regulatory compliance throughout the dispensing process.

2. Scope

This SOP applies to the dispensing of all excipients, including diluents, binders, preservatives, colorants, and viscosity enhancers used in elixir formulations in the Elixir Department. It is applicable to approved materials stored in designated areas.

3. Responsibilities

  • Warehouse Staff:
    • Retrieve approved excipients and transport them to the dispensing area.
    • Verify labels and container integrity prior to dispensing.
  • Production Operator:
    • Perform weighing and labeling activities under supervision.
  • Production Supervisor:
    • Ensure accuracy of quantity dispensed and compliance with GMP guidelines.
  • Quality Assurance:
    • Verify documentation and provide final approval for use.
See also  Elixir Department: SOP for Use of Barcode Systems During Dispensing - V 2.0

4. Accountability

The Head of the Elixir Department is accountable for ensuring adherence to this SOP and for compliance with GMP regulations during excipient dispensing operations.

5. Procedure

5.1 Requisition and Material Collection

  1. Check the Bill of Materials (BoM) and Manufacturing Batch Record (MBR) to identify required excipients and their respective quantities.
  2. Raise a material requisition form and obtain approval from the Production Head.
  3. Confirm that materials are approved by QC and labeled with ‘Approved’ status.
  4. Collect excipients from the approved storage area using clean, labeled containers.

5.2 Weighing and Equipment Preparation

  1. Ensure the dispensing area and weighing balances are clean and calibrated.
  2. Wear proper Personal Protective Equipment (PPE) including gloves, mask, apron, and cap.
  3. Transfer the excipient container into the dispensing booth under controlled conditions.
  4. Weigh the required quantity using a calibrated balance. Record the actual weight in the logbook.

5.3 Labeling and Identification

  1. Affix a “Dispensed Material” label on each container with the following:
    • Excipient Name
    • Batch Number
    • Quantity Dispensed
    • Date of Dispensing
    • Signature of Operator and Supervisor
  2. Check that the container is sealed and free of external contamination.
See also  Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0

5.4 Transfer and Storage

  1. Transfer the labeled container to the staging area for batch production.
  2. Ensure the transport trolley is clean and dedicated for the specific batch.
  3. Maintain temperature and humidity conditions if required, as per material specifications.

5.5 Documentation and Review

  1. Enter the dispensing details in the Material Dispensing Log (Annexure-1).
  2. Attach the respective Certificate of Analysis (Annexure-2) to the batch file.
  3. Complete the Approval and Release Form (Annexure-3) and forward to QA for review and release.

6. Abbreviations

  • BoM: Bill of Materials
  • MBR: Manufacturing Batch Record
  • QA: Quality Assurance
  • QC: Quality Control
  • PPE: Personal Protective Equipment
  • SOP: Standard Operating Procedure

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Certificate of Analysis (Annexure-2)
  3. Approval and Release Form (Annexure-3)

8. References

  • WHO Technical Report Series 1019 – GMP for Pharmaceutical Products
  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals
See also  Elixir Department: SOP for Reconciliation of Raw Materials Post Dispensing - 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

Date Excipient Batch No. Qty Dispensed Operator Supervisor
11/04/2025 Sodium Benzoate SB9821 1.0 kg Rajesh Kumar Sunita Reddy
11/04/2025 Sucrose SC1122 5.0 kg Ajay Mehta Kiran Joshi

Annexure-2: Certificate of Analysis (CoA)

Excipient Batch No. Test Parameter Result Complies
Sodium Benzoate SB9821 pH 7.0 Yes
Sucrose SC1122 Clarity Clear Yes

Annexure-3: Approval and Release Form

Date Excipient Batch No. Released By Approved By Remarks
11/04/2025 Sodium Benzoate SB9821 Sunita Reddy Manoj Verma Approved
11/04/2025 Sucrose SC1122 Ajay Mehta Manoj Verma Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Issue Original SOP Creation QA Head
11/04/2025 2.0 Format Update & Annexure Revision Document Harmonization QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,