Elixir Department: SOP for Handling Damaged Raw Material Packs – V 2.0

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Elixir Department: SOP for Handling Damaged Raw Material Packs – V 2.0

Standard Operating Procedure for Handling Damaged Raw Material Packs in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/035/2025
Supersedes SOP/ELX/035/2022
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 establish a standard procedure for identifying, reporting, and managing damaged raw material containers or packs received in the Elixir Department, ensuring product integrity, compliance, and traceability.

2. Scope

This SOP applies to all raw material packs including APIs, excipients, solvents, and additives received at the Elixir Department’s warehouse that are found to be physically damaged, leaking, contaminated, or improperly sealed.

3. Responsibilities

  • Warehouse Assistant:
    • Inspect incoming material packs and identify visible damages.
    • Segregate damaged containers and report to the supervisor.
  • Warehouse Supervisor:
    • Verify damage, document incident, and initiate disposition process.
  • QA Personnel:
    • Assess product integrity and determine if material is usable or needs rejection.
    • Approve final action and maintain deviation or incident report.
See also  Elixir Department: SOP for Dispensing Active Pharmaceutical Ingredients for Elixirs - V 2.0

4. Accountability

The Warehouse In-Charge is accountable for ensuring that damaged material handling follows this SOP, with oversight from the QA department

for decision making and documentation.

5. Procedure

5.1 Inspection at Receipt

  1. Upon receiving raw materials, inspect each container for:
    • Tears, punctures, or holes in packaging
    • Leaking or wet outer surfaces
    • Broken seals or tamper evidence
    • Contamination such as dust, insects, or foreign material
  2. If any damage is observed, do not move the material into the main storage area.

5.2 Segregation and Identification

  1. Move the damaged container to the designated “Damaged Material Hold Area.”
  2. Label the container as “Damaged – Under Investigation” (Red Tag) with:
    • Date
    • Material Name
    • Batch Number
    • Received By

5.3 Documentation and Intimation

  1. Enter the details of the damaged pack in the Damaged Material Register.
  2. Notify the Warehouse Supervisor and QA for joint inspection.
  3. Photograph the damage (if possible) for record keeping.
See also  Elixir Department: SOP for Control and Use of Primary Containers During Dispensing - V 2.0

5.4 Assessment by QA

  1. QA inspects the material to determine:
    • Extent and type of damage
    • Possibility of contamination or exposure
    • Integrity of primary packaging
  2. If the primary pack is intact, QA may recommend use after appropriate labeling and documentation.
  3. If the material is deemed unfit, QA will reject the batch and update the inventory status accordingly.

5.5 Disposition and Reporting

  1. Rejected material must be moved to the “Rejected Material Area.”
  2. Send a notification to the purchase team and vendor if needed.
  3. Complete the Deviation/Incident Report (Annexure-3) and attach supporting documents.
  4. All actions must be signed and approved by the QA Head.

6. Abbreviations

  • QA: Quality Assurance
  • SOP: Standard Operating Procedure
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Damaged Material Register (Annexure-1)
  2. Photographic Record and Inspection Notes (Annexure-2)
  3. Deviation/Incident Report (Annexure-3)

8. References

  • WHO Technical Report Series 986 – Annex 2: GMP Guidelines
  • 21 CFR Part 211 – Current Good Manufacturing Practice
See also  Elixir Department: SOP for Dispensing of Preservatives for Elixirs - 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: Damaged Material Register

Date Material Batch No. Type of Damage Identified By Status
11/04/2025 Sorbitol Solution SB4411 Leakage from Cap Rajesh Kumar Under QA Review

Annexure-2: Inspection Notes

Material Inspection By Observations Photo Attached
Sorbitol Solution Sunita Reddy Cap was loose; inner seal intact; minor outer leakage. Yes

Annexure-3: Deviation/Incident Report

Date Material Batch No. Deviation Type Disposition QA Approval
11/04/2025 Sorbitol Solution SB4411 Damaged Container Used after relabeling – Seal Intact Approved by QA Head

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP Document QA Head
11/04/2025 2.0 Format Standardized, Annexures Added Process Harmonization QA Head
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