Warehouse Personnel:

• Ensure safe handling, unloading, and unpacking of large bulk containers using appropriate equipment.
• Inspect bulk materials for damage, contamination, or discrepancies upon receipt.
• Record all receipt details in the Raw Material Receiving Register (Annexure-1).
• Segregate and quarantine bulk materials if any deviations are identified during receipt.

Quality Assurance (QA) Team:

• Review and verify that bulk materials are handled and unpacked in compliance with GMP requirements.
• Approve or reject bulk materials based on inspection findings and documentation verification.

Quality Control (QC) Team:

• Conduct sampling and testing of bulk materials following safe handling procedures.
• Ensure that analytical procedures are followed to confirm the quality of the bulk materials.

Procurement Department:

• Ensure suppliers provide complete documentation, including handling instructions and safety data sheets.
• Coordinate with suppliers to address any discrepancies or issues related to bulk material shipments.

4. Accountability

The Warehouse Manager is responsible for ensuring that large bulk materials are handled and unpacked safely and in compliance with this SOP. The QA Manager holds the authority to approve or reject bulk materials based on inspection and compliance with handling procedures. The Procurement Manager is responsible for ensuring that suppliers provide accurate documentation and adhere to shipment requirements.

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, including:
      • Material Safety Data Sheets (MSDS), Certificates of Analysis (CoAs), and handling instructions.
      • Shipment details, including container types (drums, IBCs) and specific unloading instructions.
   2. Ensure that all required equipment and Personal Protective Equipment (PPE) are available for safe handling.
2. Preparation of Handling Equipment and PPE
   1. Ensure that forklifts, pallet jacks, hoists, and other necessary equipment are in good working condition.
   2. Provide appropriate PPE to personnel, including gloves, safety shoes, helmets, and protective clothing.

5.2 Unloading and Movement of Bulk Containers

1. Safe Unloading Procedures
   1. Inspect the delivery vehicle to ensure containers are secured and undamaged before unloading.
   2. Use forklifts or hoists to carefully unload bulk containers, ensuring that:
      • Containers are handled gently to avoid damage.
      • Personnel maintain a safe distance during unloading to prevent accidents.
      • Hazardous materials are handled in accordance with MSDS guidelines.
2. Moving Containers to the Receiving Area
   1. Transport bulk containers to the designated receiving area using approved equipment.
   2. Ensure that containers are placed on stable, level surfaces and secured to prevent tipping.
   3. Segregate hazardous or temperature-sensitive materials in designated areas for further inspection.

5.3 Inspection and Documentation

1. Visual Inspection of Bulk Containers
   1. Inspect each bulk container for signs of damage, contamination, or leakage:
      • Check for punctures, dents, or cracks in containers.
      • Ensure that container seals and closures are intact and secure.
      • Verify that labels, batch numbers, and handling instructions are correct and legible.
2. Documentation of Receipt Details
   1. Record the following information in the Raw Material Receiving Register (Annexure-1):
      • Date of receipt and supplier information.
      • Material name, batch number, container type, and quantity received.
      • Inspection findings, including any discrepancies or damages.
   2. Notify QA immediately if any deviations are identified during the inspection.

5.4 Unpacking and Sampling

1. Unpacking Procedures
   1. Ensure that unpacking is done in a controlled environment to prevent contamination.
   2. Use approved tools and follow handling instructions for opening bulk containers safely.
   3. For hazardous materials, follow MSDS guidelines and use appropriate PPE during unpacking.
2. Sampling by Quality Control (QC)
   1. QC personnel conduct sampling according to standard procedures and handling requirements:
      • Ensure that sampling tools are clean and sterilized before use.
      • Document sampling details in the Sampling Log (Annexure-2), including date, batch number, and sample size.
      • Store samples in appropriate conditions until testing is completed.

5.5 Final Disposition of Bulk Materials

1. Approval or Rejection of Materials
   1. QA reviews inspection and testing results to determine the final disposition of bulk materials:
      • Accepted materials are labeled and moved to designated storage areas.
      • Rejected materials are labeled and moved to the rejection area with proper documentation.
2. Supplier Communication and Corrective Actions
   1. Procurement communicates with suppliers regarding any issues identified during receipt or unpacking.
   2. Ensure that suppliers implement corrective actions for future shipments if deviations are identified.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• MSDS: Material Safety Data Sheet
• CoA: Certificate of Analysis
• IBC: Intermediate Bulk Container

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS)
4. 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 Safety Guidelines for Handling Bulk Containers
• 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	Container Type	Quantity	Inspection Findings	Remarks
01/02/2025	ABC Chemicals	API-X	X-2025-001	PO-12345	Drum	200 kg	Packaging Intact, No Damage	Accepted
02/02/2025	XYZ Pharma	Excipient-Y	Y-2025-002	PO-67890	IBC	500 kg	Seal Broken, Possible Contamination	Quarantined, Pending QA Review

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Container Type	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	X-2025-001	Drum	John Doe	Identity Test	Pass	Approved for Use
03/02/2025	Excipient-Y	Y-2025-002	IBC	Jane Smith	Purity Test	Pending	Awaiting QA Decision on Contamination Risk

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 handling and unpacking large bulk material containers.
01/02/2025	2.0	Added Safety Protocols and Expanded Unpacking Procedures	Standardization of Document	QA Head	All	All	Included detailed safety guidelines and expanded sampling documentation.