Elixir Department: SOP for Handling Rejected Raw Materials During Dispensing – V 2.0

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Elixir Department: SOP for Handling Rejected Raw Materials During Dispensing – V 2.0

Standard Operating Procedure for Handling Rejected Raw Materials During Dispensing

Department Elixir Department
SOP No. SOP/ELX/014/2025
Supersedes SOP/ELX/014/2022
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 a standardized procedure for the identification, segregation, documentation, and disposal of rejected raw materials during dispensing operations in the Elixir Department, ensuring compliance with GMP and preventing mix-ups or contamination.

2. Scope

This SOP is applicable to all personnel involved in raw material handling and dispensing in the Elixir Department and covers materials that are found rejected, damaged, expired, or not meeting specified quality standards during the dispensing process.

3. Responsibilities

  • Dispensing Operator:
    • Immediately identify and report rejected materials during dispensing.
    • Segregate the material and affix “REJECTED” label.
  • Warehouse Supervisor:
    • Verify rejection and ensure transfer to the designated rejection area.
    • Inform Quality Assurance for further action.
  • Quality Assurance (QA):
    • Evaluate, document, and authorize disposal or re-testing of the material.
    • Initiate investigation and deviation handling if required.
See also  Elixir Department: SOP for Use of Barcode Systems During Dispensing - V 2.0

4. Accountability

The Head of Quality Assurance and the Head of Warehouse are accountable for compliance with the procedure for handling rejected raw materials during dispensing.

5. Procedure

5.1 Identification of Rejected Material

  1. During dispensing, observe each raw material container for the following:
    • Mismatch in label details (batch number, material name, expiry)
    • Physical damage to the container (dents, tears, leakage)
    • Signs of contamination (discoloration, odor, moisture ingress)
    • Expired or retest overdue labels
  2. If any of the above is observed, stop dispensing immediately and report to the Warehouse Supervisor.

5.2 Segregation and Labeling

  1. Move the suspected/rejected material to a separate “Rejected Material” holding area within the dispensing room or warehouse.
  2. Affix a “REJECTED” status label (Annexure-1) on the container, clearly stating:
    • Material Name
    • Batch Number
    • Reason for Rejection
    • Date of Rejection
    • Initials of reporting person
See also  Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0

5.3 QA Evaluation

  1. QA shall visit the rejection area and inspect the material visually and physically.
  2. Review Certificate of Analysis (CoA), approval documents, and sampling records.
  3. Decide on the final disposition:
    • Return to Vendor
    • Re-test and Re-evaluation
    • Final Destruction
  4. Record the outcome in the Rejected Material Record Log (Annexure-2).

5.4 Documentation

  1. Fill the Rejected Material Report and attach to the respective batch documentation.
  2. Document deviation, if applicable, as per deviation handling SOP.
  3. All rejected entries must be reviewed during batch release and PQR.

5.5 Final Disposal

  1. Disposal shall be done as per SOP on Waste and Destruction of Rejected Materials.
  2. Witnessed by QA and logged in the Rejection Disposal Logbook.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • CoA: Certificate of Analysis
  • PQR: Product Quality Review
See also  Elixir Department: SOP for Handling Damaged Raw Material Packs - V 2.0

7. Documents

  1. Rejected Material Status Label (Annexure-1)
  2. Rejected Material Record Log (Annexure-2)
  3. Deviation Report (if applicable)
  4. Disposal Record Log

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Rejected Material Status Label

Material Name Batch No. Reason for Rejection Date Rejected By
Sorbitol SR0425A Container Leak 13/04/2025 Rajesh Kumar

Annexure-2: Rejected Material Record Log

Date Material Batch No. Rejection Reason Disposition QA Verified By
13/04/2025 Sorbitol SR0425A Container Leak Destruction Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial Version New SOP QA Head
13/04/2025 2.0 Added structured rejection handling & labeling requirements Audit Recommendation QA Head
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