Elixir Department: SOP for Verification of Raw Materials Before Dispensing – V 2.0

Posted on By

Elixir Department: SOP for Verification of Raw Materials Before Dispensing – V 2.0

Standard Operating Procedure for Verification of Raw Materials Before Dispensing

Department Elixir Department
SOP No. SOP/ELX/011/2025
Supersedes SOP/ELX/011/2022
Page No. Page 1 of 8
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To define the procedure for verifying raw materials prior to dispensing in order to ensure correct identity, quantity, status, and suitability for elixir manufacturing. This SOP ensures accuracy, traceability, and GMP compliance.

2. Scope

This procedure applies to all raw materials including APIs, excipients, and solvents stored in the Elixir Department’s approved material stores and intended for batch-wise dispensing.

3. Responsibilities

  • Warehouse Operator:
    • Perform physical checks on the selected materials.
    • Ensure correct selection and condition of the material containers.
  • Warehouse Supervisor:
    • Verify material labels, status, and documentation.
  • QA Officer:
    • Cross-check material identity and approval status.
    • Authorize the material for dispensing.
See also  Elixir Department: SOP for Dispensing Active Pharmaceutical Ingredients for Elixirs - V 2.0

4. Accountability

The Head of Quality Assurance and the Head of Warehouse are accountable for ensuring that only approved and verified raw materials are used in the dispensing process.

5. Procedure

5.1 Receipt of Dispensing Requisition

  1. Review the Batch Manufacturing Record (BMR) and Material Requisition Slip (Annexure-1).
  2. Ensure the details mentioned include:
    • Product Name
    • Batch Number
    • Material Name & Code
    • Required Quantity

5.2 Material Selection from Storage

  1. Locate the material in the approved storage zone based on FIFO (First In First Out) or FEFO (First Expiry First Out) as applicable.
  2. Ensure the container carries a label with the following:
    • Material Name
    • Material Code
    • Batch Number
    • Manufacturer / Supplier Name
    • Quantity Available
    • Retest/Expiry Date
    • Status Label (Approved)

5.3 Verification Checks

  1. Match each material’s details with the corresponding COA and Approval Record.
  2. Ensure the container is not damaged, leaking, tampered, or illegible.
  3. Cross-check the following against the BMR:
    • Material Name & Code
    • Batch Number
    • Status (Approved)
    • Available Quantity
    • Retest/Expiry Date is valid
  4. For controlled materials or restricted-use items, ensure QA authorization is obtained.
See also  Elixir Department: SOP for Use of Barcode Systems During Dispensing - V 2.0

5.4 Documentation

  1. Fill in the Raw Material Verification Checklist (Annexure-2).
  2. Warehouse Supervisor and QA must sign the checklist before dispensing begins.
  3. Attach the completed checklist to the batch dispensing documents.

5.5 Handling of Discrepancies

  1. If any mismatch, labeling error, expired status, or damaged container is observed:
    • Segregate the material immediately.
    • Label it as “Under Investigation.”
    • Inform QA and document the deviation.

5.6 Verification During Dispensing

  1. Before opening the container for dispensing:
    • Verify label again.
    • Ensure material is clean and free from foreign matter.
  2. Proceed with dispensing only after QA re-verification.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • COA: Certificate of Analysis
  • QA: Quality Assurance

See also  Elixir Department: SOP for Control and Use of Primary Containers During Dispensing - V 2.0

7. Documents

  1. Material Requisition Slip (Annexure-1)
  2. Raw Material Verification Checklist (Annexure-2)

8. References

  • WHO GMP Guidelines – Materials Management
  • 21 CFR Part 211 – Subpart E: Control of Components

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 Requisition Slip

Date Product Name Batch No. Material Name Code Qty Required Requested By
13/04/2025 Elixir A EA0425-001 Sorbitol RM-SOR-001 25 kg Rajesh Kumar

Annexure-2: Raw Material Verification Checklist

Item Status (Yes/No) Remarks
Correct Material Selected Yes Label matched
Batch No. & Expiry Validated Yes Retest due: 10/2026
Container Integrity Confirmed Yes No damage
QA Approval Present Yes Approved label affixed

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial Release New SOP QA Head
13/04/2025 2.0 Added discrepancy handling steps Audit Requirement QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,