SOP Guide for Pharma

SOP for Documentation of Transit Conditions for Sensitive Raw Materials – V 2.0

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SOP for Documentation of Transit Conditions for Sensitive Raw Materials – V 2.0

Standard Operating Procedure for Documentation of Transit Conditions for Sensitive Raw Materials

Department Warehouse / Quality Assurance / Logistics / Procurement
SOP No. SOP/RM/046/2025
Supersedes SOP/RM/046/2022
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 documenting and verifying transit conditions of sensitive raw materials. Ensuring that materials are transported under specified environmental conditions is critical to maintaining their quality, efficacy, and compliance with regulatory standards.

2. Scope

This SOP applies to all temperature-sensitive, humidity-sensitive, and light-sensitive raw materials transported to the facility. It includes procedures for monitoring, recording, and verifying transit conditions, and handling deviations.

3. Responsibilities

  • Logistics Team: Ensure transportation under specified conditions, monitor transit data, and submit reports.
  • Quality Assurance (QA) Team: Review transit condition documentation, approve/reject materials, and handle deviations.
  • Warehouse Personnel: Inspect received materials, document conditions, and report discrepancies.
  • Procurement Department: Ensure suppliers comply with transit requirements and provide necessary documentation.

4. Accountability

The Logistics Manager is responsible for maintaining transit conditions and documentation. The QA Manager holds the authority to approve or reject materials based on transit data.

The Warehouse Manager ensures accurate receipt documentation, while the Procurement Manager oversees supplier compliance.
See also  SOP for Handling and Storing Documents Related to Raw Material Receiving - V 2.0

5. Procedure

5.1 Pre-Shipment Preparations

  1. Define Transit Conditions: Procurement and QA specify required conditions (temperature, humidity, light protection) in the purchase order.
  2. Pre-Loading Checks: Logistics ensures pre-conditioning of transport vehicles and installs calibrated data loggers.

5.2 Monitoring and Recording Transit Conditions

  1. Data Logger Use: Install data loggers to monitor temperature, humidity, and light exposure throughout transit.
  2. Documentation: Upon receipt, download data and generate the Transit Condition Report (Annexure-2).

5.3 Verification of Transit Conditions Upon Receipt

  1. Initial Inspection: Warehouse personnel check for physical damage, temperature excursions, or exposure to light.
  2. QA Review: QA compares data logger readings with specified conditions and decides on material disposition.

5.4 Handling Deviations in Transit Conditions

  1. Deviation Documentation: Record deviations in the Transit Deviation Report (Annexure-4) and quarantine the affected materials.
  2. Corrective Actions: QA investigates deviations and coordinates with Procurement and Logistics for resolution.

See also  SOP for Managing Retained Samples of Quarantined Raw Materials - V 2.0

5.5 Final Disposition of Sensitive Raw Materials

  1. Approval or Rejection: QA approves compliant materials for storage and rejects non-compliant ones, documenting in the Sensitive Material Disposition Log (Annexure-5).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • RH: Relative Humidity

7. Documents

  1. Transit Preparation Log (Annexure-1)
  2. Transit Condition Report (Annexure-2)
  3. Sensitive Material Receiving Register (Annexure-3)
  4. Transit Deviation Report (Annexure-4)
  5. Sensitive Material Disposition Log (Annexure-5)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Transit Preparation Log

Date Material Name Batch Number Transporter Pre-Loading Temperature Humidity Control Data Logger Installed Remarks
01/02/2025 API-X X-2025-001 CoolTrans Ltd. 4°C 55% RH Yes Ready for Shipment
02/02/2025 Biologic-Y BIO-2025-002 SafeCargo -20°C N/A Yes Opaque Packaging Used

See also  SOP for Receiving and Handling of Controlled Substances in Raw Material Stores - V 2.0

Annexure-2: Transit Condition Report

Date Material Name Batch Number Recorded Temperature Range Recorded Humidity Range Light Exposure Deviation Noted Remarks
01/02/2025 API-X X-2025-001 2-6°C 48-52% RH None No Approved
02/02/2025 Biologic-Y BIO-2025-002 -18 to -22°C N/A None Yes Minor Excursion

Annexure-3: Sensitive Material Receiving Register

Date Material Name Batch Number Inspection Findings Transit Conditions Verified Final Disposition Remarks
01/02/2025 API-X X-2025-001 No Damage Yes Approved Stored at 4°C
02/02/2025 Biologic-Y BIO-2025-002 Condensation Noted Pending Quarantined Awaiting QA Review

Annexure-4: Transit Deviation Report

Deviation Report No. Date Material Name Batch Number Nature of Deviation Root Cause Analysis Corrective Action Status
TD-001/2025 02/02/2025 Biologic-Y BIO-2025-002 Temperature Excursion (-18°C) Faulty Transport Freezer Supplier Replaced Freezer Closed

Annexure-5: Sensitive Material Disposition Log

Date Material Name Batch Number Disposition Approved By Remarks
01/02/2025 API-X X-2025-001 Approved QA Manager Meets All Conditions
02/02/2025 Biologic-Y BIO-2025-002 Rejected QA Manager Temperature Excursion Noted

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 Deviation Handling Procedures Standardization QA Head
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