Elixir Department: SOP for Controlled Substance Dispensing for Elixirs – V 2.0

Posted on By

Elixir Department: SOP for Controlled Substance Dispensing for Elixirs – V 2.0

Standard Operating Procedure for Dispensing of Controlled Substances in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/030/2025
Supersedes SOP/ELX/030/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

This SOP outlines the standardized procedure for secure, accurate, and regulatory-compliant dispensing of controlled substances used in elixir formulations. It ensures traceability, minimizes risks of misuse, and aligns with national regulatory requirements.

2. Scope

This SOP applies to all activities related to the dispensing of controlled substances in the Elixir Department. It includes material request, authorization, handling, weighing, labeling, documentation, and return of excess quantity if applicable.

3. Responsibilities

  • Warehouse In-Charge:
    • Ensure controlled substances are stored in designated secured locations.
    • Maintain updated stock and access logs.
  • Authorized Dispensing Officer:
    • Perform accurate weighing and labeling of controlled substances.
    • Ensure dispensing is done under supervision and with authorization.
  • Production Supervisor:
    • Supervise the entire dispensing activity and cross-verify the quantity.
  • QA/QC Personnel:
    • Approve the dispensed material and ensure traceability documentation is complete.
See also  Elixir Department: SOP for Control and Use of Primary Containers During Dispensing - V 2.0

4. Accountability

The Production Head of the Elixir Department is accountable for enforcing this SOP. Only

personnel authorized by the QA Head and registered under local drug control regulations shall dispense controlled substances.

5. Procedure

5.1 Authorization and Requisition

  1. Initiate a Controlled Substance Dispensing Requisition Form, signed by the Production Head.
  2. Verify material status (Approved) in inventory and ensure the substance is available.
  3. Ensure the person initiating and handling the substance is authorized and trained.

5.2 Secured Dispensing Setup

  1. Access the designated secure room/dispensing booth with limited authorized access.
  2. Ensure the area is monitored via CCTV and access logs are maintained.
  3. Verify the container label for:
    • Material Name
    • Batch Number
    • Expiry Date
    • Quantity in Stock

5.3 Weighing Procedure

  1. Use a calibrated analytical balance placed within the secure dispensing area.
  2. Weigh the required quantity as per the approved MBR. Ensure zero error tolerance.
  3. Record the actual quantity dispensed in the logbook and on the container label.

See also  Elixir Department: SOP for Entry and Exit Procedure for Dispensing Area - V 2.0

5.4 Labeling and Sealing

  1. Affix the “Controlled Substance Dispensed” label with:
    • Name of Substance
    • Quantity Dispensed
    • Batch Number
    • Date of Dispensing
    • Dispensed By
    • Verified By
  2. Seal the container and ensure the seal is tamper-evident.
  3. Transfer the dispensed container immediately to the designated storage area for production use.

5.5 Documentation and Return of Excess

  1. Enter details in the Material Dispensing Log (Annexure-1) and Controlled Substance Register.
  2. Attach the CoA of the material to the batch file (Annexure-2).
  3. Fill the Approval and Release Form (Annexure-3) and have it reviewed by QA.
  4. If any excess material remains, document the quantity and return it immediately to the secure storage with a return note.

5.6 Record Retention

  1. Retain all records, including access logs, requisition forms, and dispensing logs for a minimum of 5 years.
  2. Ensure digital records are password-protected and backed up regularly.

6. Abbreviations

  • QA: Quality Assurance
  • QC: Quality Control
  • MBR: Manufacturing Batch Record
  • SOP: Standard Operating Procedure
  • CoA: Certificate of Analysis

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 Environmental Conditions for Dispensing of Elixirs - V 2.0

8. References

  • Narcotic Drugs and Psychotropic Substances Act (India)
  • 21 CFR Part 1300–1321 – US DEA Controlled Substances Regulations
  • WHO Guidelines on Controlled Substances Management

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 Substance Batch No. Qty Dispensed Dispensed By Verified By
11/04/2025 Codeine Phosphate CDP4521 0.200 kg Rajesh Kumar Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Substance Batch No. Test Result Complies
Codeine Phosphate CDP4521 Identification Positive Yes

Annexure-3: Approval and Release Form

Date Substance Batch No. Released By Approved By Remarks
11/04/2025 Codeine Phosphate CDP4521 Ajay Mehta Manoj Verma Approved for ELX-Batch-203

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP Implementation QA Head
11/04/2025 2.0 Format Update and Record Retention Policy Addition Compliance with Revised Internal SOP Format QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,