SOP for Verification and Compliance of Storage Conditions Before Receipt – V 2.0

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SOP for Verification and Compliance of Storage Conditions Before Receipt – V 2.0

Standard Operating Procedure for Verification and Compliance of Storage Conditions Before Receipt

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/054/2025
Supersedes SOP/RM/054/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for verifying the compliance of storage and transport conditions of raw materials before they are officially received at the facility. The aim is to ensure materials have been handled under conditions that maintain their integrity, quality, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials received at the facility. It covers procedures for verifying temperature, humidity, and handling conditions during storage and transportation from the supplier to the receiving site.

3. Responsibilities

  • Warehouse Personnel: Check storage condition documentation, inspect transportation equipment, and record compliance status.
  • Quality Assurance (QA): Review compliance records, ensure materials meet predefined storage conditions, and approve or reject materials based on findings.
  • Quality Control (QC): Perform additional testing if storage conditions were compromised during transit.
  • Procurement Department: Ensure suppliers comply with contractual storage and transport conditions and address any discrepancies.
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4. Accountability

The Warehouse Manager is responsible for the accurate verification of storage conditions upon receipt. The QA Manager holds authority to approve or reject materials based on compliance with storage requirements, while the Procurement Manager ensures supplier adherence to storage specifications. The QC Manager evaluates material quality if storage deviations are identified.

5. Procedure

5.1 Pre-Receipt Preparations

  1. Supplier Requirements:

    • Procurement ensures suppliers provide detailed storage and transport conditions in the purchase agreement.
    • Suppliers must include temperature and humidity logs, if applicable, with each shipment.
  2. Warehouse Preparations:

    • Warehouse personnel are trained on reviewing and documenting storage conditions upon receipt.
    • Ensure the availability of temperature and humidity monitoring equipment for on-site verification.

5.2 Verification of Storage Conditions at Receiving

  1. Documentation Review:

    • Upon delivery, Warehouse personnel review the supplier-provided storage condition documentation, including:
      • Temperature and humidity logs.
      • Evidence of compliance with specified storage conditions during transit.
    • Record findings in the Storage Condition Verification Log (Annexure-1).
  2. Inspection of Transport Conditions:

    • Inspect transportation equipment (e.g., refrigerated trucks, insulated containers) to ensure compliance with required conditions.
    • Use in-house temperature and humidity monitoring devices to verify real-time conditions.
    • Document results in the Transport Inspection Checklist (Annexure-2).

5.3 Handling Deviations in Storage Conditions

  1. Identification of Deviations:

    • If storage conditions deviate from the specified range, segregate the materials and label them as “UNDER REVIEW.”
    • Document deviations in the Storage Condition Deviation Report (Annexure-3).
  2. QA Review and Corrective Actions:

    • QA reviews deviation reports and determines the impact on material integrity.
    • If necessary, QC performs additional testing to confirm material quality.
    • Corrective actions and final disposition are recorded in the Material Disposition Log (Annexure-4).
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5.4 Supplier Communication and Resolution

  1. Supplier Notification:

    • Procurement contacts the supplier regarding storage condition deviations.
    • Request corrective actions, including improved packaging, transportation conditions, or material replacement.
  2. Corrective Action Documentation:

    • Document the supplier’s corrective actions in the Corrective Action Log (Annexure-5).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • QC: Quality Control

7. Documents

  1. Storage Condition Verification Log (Annexure-1)
  2. Transport Inspection Checklist (Annexure-2)
  3. Storage Condition Deviation Report (Annexure-3)
  4. Material Disposition Log (Annexure-4)
  5. Corrective Action Log (Annexure-5)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department
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11. Annexures

Annexure-1: Storage Condition Verification Log

Date Material Name Batch Number Supplier Provided Temp (°C) Required Temp (°C) Humidity Level (%) Verified By Remarks
01/02/2025 API-X X-2025-001 4°C 2-8°C 45% John Doe Within Limits
01/02/2025 Excipient-Y Y-2025-002 15°C 10-15°C 60% Jane Smith Humidity Slightly Elevated

Annexure-2: Transport Inspection Checklist

Date Material Name Batch Number Transport Condition Packaging Integrity Inspection Result Inspected By
01/02/2025 API-X X-2025-001 Refrigerated Truck Intact Pass John Doe

Annexure-3: Storage Condition Deviation Report

Date Material Name Batch Number Deviation Description Impact on Material Reported By Status
02/02/2025 Excipient-Y Y-2025-002 Humidity Above Limit Potential Quality Impact Jane Smith Under Review

Annexure-4: Material Disposition Log

Date Material Name Batch Number Disposition Approved By Remarks
03/02/2025 API-X X-2025-001 Approved QA Manager Meets Specifications

Annexure-5: Corrective Action Log

Date Supplier Name Material Name Batch Number Corrective Action Taken Follow-Up Required
03/02/2025 PharmaSuppliers Ltd. Excipient-Y Y-2025-002 Improved Packaging to Reduce Humidity Exposure Yes

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Added Transport Inspection Procedures Standardization QA Head
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