SOP Guide for Pharma

SOP for Handling Raw Materials Arriving Outside of Working Hours – V 2.0

Auditor

SOP for Handling Raw Materials Arriving Outside of Working Hours – V 2.0

Standard Operating Procedure for Handling Raw Materials Arriving Outside of Working Hours

Department Warehouse / Quality Assurance / Security
SOP No. SOP/RM/058/2025
Supersedes SOP/RM/058/2022
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 receiving and handling raw materials that arrive at the facility outside of standard working hours. It ensures proper security, documentation, and compliance with Good Manufacturing Practices (GMP) even during off-hours.

2. Scope

This SOP applies to all raw materials received outside the regular working hours, including weekends, holidays, and night shifts. It covers responsibilities, inspection, documentation, and temporary storage until formal processing can occur during regular hours.

3. Responsibilities

  • Security Personnel: Verify and record the arrival of raw materials, check documentation, and coordinate with the warehouse team on the next working day.
  • Warehouse Personnel: Inspect the materials during the next shift, verify documentation, and ensure compliance with standard receipt procedures.
  • Quality Assurance (QA): Review records, inspect materials, and approve or reject based on standard acceptance criteria.
  • Procurement Department: Inform suppliers of off-hour delivery protocols and handle discrepancies.

See also  SOP for Receiving and Managing Multiple Batches of the Same Raw Material - V 2.0

4. Accountability

The

Security Manager is responsible for ensuring that materials arriving outside working hours are properly logged and secured. The Warehouse Manager ensures thorough inspection during regular hours. The QA Manager approves or rejects materials after verification, and the Procurement Manager coordinates with suppliers for adherence to delivery schedules.

5. Procedure

5.1 Pre-Approval for Off-Hours Deliveries

  1. Supplier Notification:
    • Procurement must inform suppliers that off-hours deliveries require prior approval from the Warehouse and Security Managers.
    • Approved deliveries should be accompanied by complete documentation (Purchase Order, Delivery Note, etc.).

5.2 Receiving Materials Outside of Working Hours

  1. Security Check:
    • Security personnel must:
      • Verify delivery personnel credentials and vehicle documentation.
      • Check for visible damages to packaging or signs of tampering.
    • Record the delivery in the Off-Hours Material Receipt Log (Annexure-1).
  2. Temporary Storage:
    • Store the materials in a designated, secure quarantine area marked as “Pending Inspection.”
    • Ensure that temperature-sensitive materials are stored under appropriate conditions.

5.3 Inspection During Regular Working Hours

  1. Warehouse Inspection:
    • The warehouse team inspects materials the next working day, verifying:
      • Packaging integrity.
      • Documentation completeness (PO, Delivery Note, MSDS, etc.).
      • Material labeling (batch number, expiry date, etc.).
    • Document findings in the Material Inspection Log (Annexure-2).
  2. QA Review:
    • QA reviews inspection reports and determines material disposition (approve, quarantine, or reject).
    • Record disposition in the Material Disposition Log (Annexure-3).
See also  SOP for Receiving Temperature-Sensitive Raw Materials - V 2.0

5.4 Handling Discrepancies

  1. Identification of Issues:
    • If discrepancies (e.g., damaged packaging, missing documentation) are found, materials must be segregated and labeled as “UNDER REVIEW.”
    • Document discrepancies in the Off-Hours Delivery Discrepancy Report (Annexure-4).
  2. Supplier Coordination:
    • Procurement contacts suppliers for clarification or corrective actions.
    • Document supplier responses in the Corrective Action Log (Annexure-5).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • MSDS: Material Safety Data Sheet

7. Documents

  1. Off-Hours Material Receipt Log (Annexure-1)
  2. Material Inspection Log (Annexure-2)
  3. Material Disposition Log (Annexure-3)
  4. Off-Hours Delivery Discrepancy Report (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

11. Annexures

See also  SOP for Receiving Organic Solvents and Other Volatile Raw Materials - V 2.0

Annexure-1: Off-Hours Material Receipt Log

Date Material Name Batch Number Supplier Name Received By (Security) Remarks
01/02/2025 API-X X-2025-001 PharmaChem Ltd. Ramesh Kumar No Visible Damage
01/02/2025 Excipient-Y Y-2025-002 HealthSupplies Pvt. Ltd. Sunita Sharma Packing Slightly Torn

Annexure-2: Material Inspection Log

Date Material Name Batch Number Inspected By Condition Remarks
02/02/2025 API-X X-2025-001 Ajay Patel Good Approved for Storage
02/02/2025 Excipient-Y Y-2025-002 Priya Desai Damaged Sent for QA Review

Annexure-3: Material Disposition Log

Date Material Name Batch Number Disposition Approved By Remarks
03/02/2025 API-X X-2025-001 Approved QA Manager (Anjali Mehra) Ready for Use
03/02/2025 Excipient-Y Y-2025-002 Rejected QA Manager (Anjali Mehra) Packaging Integrity Compromised

Annexure-4: Off-Hours Delivery Discrepancy Report

Date Material Name Batch Number Discrepancy Reported By Status
02/02/2025 Excipient-Y Y-2025-002 Torn Packaging Priya Desai Under Review

Annexure-5: Corrective Action Log

Date Supplier Name Material Name Batch Number Corrective Action Taken Follow-Up Required
04/02/2025 HealthSupplies Pvt. Ltd. Excipient-Y Y-2025-002 Replaced Damaged Batch 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 Updated Off-Hours Handling Procedures Compliance Improvement QA Head
Exit mobile version