Standard Operating Procedure for Receiving Raw Materials with Special Handling Instructions

Department	Warehouse / Quality Assurance / Quality Control / Procurement
SOP No.	SOP/RM/035/2025
Supersedes	SOP/RM/035/2022
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) defines the process for the safe and compliant receipt of raw materials that require special handling instructions. These materials may include hazardous chemicals, temperature-sensitive items, moisture-sensitive products, and materials with unique storage or safety requirements. This SOP ensures:

• Safe unloading, inspection, and documentation of materials with special handling needs.
• Compliance with Good Manufacturing Practices (GMP), safety regulations, and supplier specifications.
• Proper coordination between Procurement, Warehouse, Quality Assurance (QA), and Quality Control (QC) teams.
• Effective segregation, labeling, and storage of materials with specific handling requirements.

2. Scope

This SOP applies to all raw materials received at the facility that require special handling, including but not limited to:

• Hazardous or toxic chemicals (flammable, corrosive, reactive substances).
• Temperature-sensitive materials (requiring refrigeration, freezing, or controlled ambient conditions).
• Moisture-sensitive materials (requiring desiccation or moisture-controlled environments).
• Materials with supplier-specific handling or storage instructions.

It covers procedures for receipt, inspection, documentation, segregation, and storage of such materials.

3. Responsibilities

• Warehouse Personnel:
  • Ensure proper unloading, inspection, and handling of materials with special instructions.
  • Use appropriate Personal Protective Equipment (PPE) and follow specific handling protocols.
  • Record receipt details and special handling instructions in the Raw Material Receiving Register (Annexure-1).
  • Segregate and store materials according to their specified handling requirements.
• Quality Assurance (QA) Team:
  • Review and verify that materials are received and handled in compliance with supplier specifications and GMP requirements.
  • Approve or reject materials based on inspection findings and compliance with special handling protocols.
• Quality Control (QC) Team:
  • Conduct sampling and testing of materials as required, following special handling instructions during the process.
  • Ensure analytical procedures align with the material’s handling and storage requirements.
• Procurement Department:
  • Ensure suppliers provide complete documentation detailing special handling and storage instructions.
  • Coordinate with suppliers and warehouse teams to address any discrepancies or issues related to handling instructions.

4. Accountability

The Warehouse Manager is responsible for ensuring that all raw materials with special handling instructions are received and managed according to this SOP. The QA Manager has the authority to approve, quarantine, or reject materials based on inspection results and compliance with handling requirements. Any deviations from this SOP must be documented and approved by QA.

5. Procedure

5.1 Pre-Receipt Preparations

1. Review of Purchase Orders and Supplier Documentation
   1. Procurement provides the Warehouse with the purchase order (PO) and supplier documentation, specifying special handling requirements (e.g., temperature control, hazardous material protocols).
   2. Ensure the shipment includes Material Safety Data Sheets (MSDS), Certificates of Analysis (CoAs), and any other relevant safety or handling documentation.
2. Preparation of Handling Equipment and PPE
   1. Ensure that necessary handling equipment (e.g., forklifts, pallet jacks, temperature loggers) is available and calibrated.
   2. Ensure personnel have access to and are trained in using appropriate PPE, including gloves, respirators, face shields, and protective clothing.
3. Setup of Receiving Area
   1. Prepare a designated receiving area with proper containment and environmental controls (e.g., temperature-controlled zones, spill containment kits).
   2. Ensure that the receiving area is secured and restricted to authorized personnel only.

5.2 Receiving and Inspection

1. Unloading and Initial Inspection
   1. Unload materials carefully, ensuring that special handling protocols are followed (e.g., minimize exposure time for temperature-sensitive materials, avoid physical shocks for fragile items).
   2. Inspect external packaging for signs of damage, leakage, or incorrect labeling.
2. Verification of Special Handling Requirements
   1. Verify that the shipment complies with the special handling instructions provided by the supplier:
      • For temperature-sensitive materials, check temperature loggers or indicators to ensure materials remained within specified temperature ranges during transit.
      • For hazardous materials, verify the integrity of containment and ensure hazard labels are intact.
      • For moisture-sensitive materials, inspect desiccants and moisture indicators for signs of exposure.
   2. Document any discrepancies or deviations in the Raw Material Receiving Register (Annexure-1) and notify QA immediately.

5.3 Documentation and Quarantine

1. Recording in Raw Material Receiving Register
   1. Record all relevant receipt details, including:
      • Date of receipt, supplier name, and PO number.
      • Material name, batch number, quantity, and any special handling requirements.
      • Inspection findings and compliance with handling protocols.
2. Quarantine and Labeling
   1. Segregate materials requiring special handling in designated quarantine areas with appropriate signage indicating the nature of the material (e.g., “Refrigerate Immediately,” “Handle with Care – Hazardous Material”).
   2. Label materials based on inspection status:
      • “Hold” for materials pending QA review and QC testing.
      • “Rejected” for materials not compliant with special handling instructions.

5.4 QA Review and QC Testing

1. QA Review of Documentation and Inspection Findings
   1. QA reviews the receiving documentation and supplier-provided handling instructions to ensure compliance.
   2. For materials in quarantine, QA conducts a secondary inspection to confirm that special handling protocols were maintained during receipt.
2. QC Sampling and Testing
   1. QC conducts sampling and testing in accordance with special handling instructions, ensuring that the integrity of sensitive materials is not compromised during analysis.
   2. Document test results and communicate findings to QA for final disposition.

5.5 Final Disposition

1. Acceptance
   1. Materials that meet all inspection and testing criteria are labeled “Accepted” and stored according to their specific handling requirements (e.g., refrigeration, desiccation).
   2. Update the Raw Material Receiving Register to reflect the accepted status and ensure traceability.
2. Rejection
   1. Materials that fail to meet special handling requirements are labeled “Rejected” and moved to the designated rejection area with proper containment measures.
   2. Document the reason for rejection and initiate a non-conformance report.
3. Supplier Notification and Corrective Action
   1. Procurement contacts the supplier to report handling-related discrepancies and coordinates returns, replacements, or corrective actions.
   2. Document all communications with the supplier and update handling protocols if necessary.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• MSDS: Material Safety Data Sheet

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Purchase Orders (PO), Invoices, and Supplier Documentation
4. Material Safety Data Sheets (MSDS)
5. Certificates of Analysis (CoAs)
6. Deviation Reports and Non-Conformance Logs

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• OSHA Hazard Communication Standard (29 CFR 1910.1200)
• Company-Specific Procurement, QA, and Warehouse Policies

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receiving Register

Date	Supplier Name	Material Name	Batch Number	PO Number	Quantity	Special Handling Requirements	Remarks
01/02/2025	ABC Chemicals	Temperature-Sensitive API-X	X-2025-001	PO-12345	50 kg	2-8°C, Avoid Freezing	Accepted, Stored in Refrigeration
02/02/2025	XYZ Pharma	Hazardous Chemical-Y	Y-2025-002	PO-67890	100 kg	Corrosive, Use PPE	Quarantined, Pending QA Review

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	Temperature-Sensitive API-X	X-2025-001	John Doe	Potency Test	Pass	Approved for Use
03/02/2025	Hazardous Chemical-Y	Y-2025-002	Jane Smith	Purity Test	Fail	Rejected Due to Contamination

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head	All	All	Established procedures for receiving raw materials with special handling instructions.
01/02/2025	2.0	Enhanced Handling Protocols	Standardization of Document	QA Head	All	All	Added detailed guidelines for hazardous and temperature-sensitive materials.