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.

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).

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

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