Elixir Department: SOP for Dispensing Active Pharmaceutical Ingredients for Elixirs – V 2.0

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Elixir Department: SOP for Dispensing Active Pharmaceutical Ingredients for Elixirs – V 2.0

Standard Operating Procedure for Dispensing Active Ingredients in Elixir Production

Department Elixir Department
SOP No. SOP/ELX/027/2025
Supersedes SOP/ELX/027/2022
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 define a standardized method for the accurate, safe, and contamination-free dispensing of active pharmaceutical ingredients (APIs) used in elixir formulations. This ensures compliance with cGMP and maintains the integrity and traceability of dispensed materials.

2. Scope

This SOP is applicable to all authorized production and warehouse personnel involved in the dispensing of APIs intended for elixir manufacturing within the Elixir Department. It covers materials approved by Quality Control (QC) and includes all activities from requisition to documentation.

3. Responsibilities

  • Warehouse Staff:
    • Retrieve approved APIs and verify details before dispensing.
    • Ensure cleanliness and readiness of the dispensing area.
  • Production Pharmacist:
    • Supervise the dispensing activity and verify the correct quantity and label.
  • QA Personnel:
    • Conduct in-process checks and authorize the release of dispensed material.
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4. Accountability

The Production Head of the Elixir Department is accountable for ensuring

the implementation of this SOP and compliance with GMP requirements during the dispensing of APIs.

5. Procedure

5.1 Requisition and Preparation

  1. Verify the manufacturing batch record (MBR) to determine the quantity of API required.
  2. Generate a dispensing request and ensure approval by the Production Head.
  3. Confirm availability and release status of API in the inventory management system.
  4. Check cleanliness of dispensing equipment, weighing balances, containers, and PPE.

5.2 Verification and Weighing

  1. Retrieve the required API from the approved material storage area.
  2. Check and verify the following on the container label:
    • Material Name
    • Batch Number
    • Expiry Date
    • Storage Condition
  3. Bring the container to the dispensing booth. Ensure differential pressure is maintained.
  4. Calibrate the balance prior to use and record in the calibration log.
  5. Weigh the required quantity using a clean, labeled container. Record the actual quantity weighed.
See also  Elixir Department: SOP for Handling Material Spillage in Dispensing Area - V 2.0

5.3 Labeling and Transfer

  1. Affix a ‘Dispensed’ label with the following information:
    • Name of Material
    • Quantity Weighed
    • Batch Number
    • Weighed By
    • Date
  2. Seal the container securely and transfer it to the staging area with appropriate documentation.
  3. Ensure transport trolley or containers are clean and dedicated to API transfer.

5.4 Documentation and Review

  1. Update the Material Dispensing Log (Annexure-1) with complete information.
  2. Attach the Certificate of Analysis (Annexure-2) for batch-specific quality confirmation.
  3. Fill out the Approval and Release Form (Annexure-3) and forward to QA for review.
  4. Retain copies of all records as part of the batch production file.

6. Abbreviations

  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • QC: Quality Control
  • MBR: Manufacturing Batch Record
  • 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

  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
  • 21 CFR Part 211 – Current Good Manufacturing Practice
See also  Elixir Department: SOP for Dispensing Under Laminar Airflow Cabinet - 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 Material Batch No. Qty Weighed Weighed By Checked By
11/04/2025 Diphenhydramine HCl DPH2201 1.5 kg Rajesh Kumar Sunita Reddy
11/04/2025 Paracetamol PCT5544 3.0 kg Ajay Mehta Kiran Joshi

Annexure-2: Certificate of Analysis (CoA)

Material Batch No. Test Result Status
Diphenhydramine HCl DPH2201 Identification Complies Pass
Paracetamol PCT5544 Assay 99.3% Pass

Annexure-3: Approval and Release Form

Date Material Batch No. Released By Approved By Remarks
11/04/2025 Diphenhydramine HCl DPH2201 Sunita Reddy Manoj Verma Approved for Batch #ELX1001
11/04/2025 Paracetamol PCT5544 Ajay Mehta Manoj Verma Approved for Batch #ELX1002

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP creation QA Head
11/04/2025 2.0 Format revision; alignment with updated GMP practices Document standardization QA Head
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