Standard Operating Procedure for Receiving Material

Purpose:

The purpose of this SOP is to outline the procedures for receiving pharmaceutical products, including inspection, documentation, and quarantine processes, to ensure compliance with regulatory requirements and maintain product integrity.

Scope:

This SOP applies to all personnel involved in the receiving process of pharmaceutical products at warehouse facilities.

Responsibilities:

• Warehouse Manager: Overall responsibility for ensuring compliance with this SOP and overseeing the receiving process.
• Receiving Personnel: Responsible for executing the receiving procedures outlined in this SOP.
• Quality Assurance (QA) Department: Responsible for overseeing the inspection and documentation of received pharmaceutical products.

Procedure:

1. Upon arrival of a shipment, the receiving personnel shall notify the Warehouse Manager and QA Department.
2. The receiving personnel shall visually inspect the shipment for any signs of damage or tampering.
3. If any damage or discrepancies are observed, the receiving personnel shall immediately inform the Warehouse Manager and QA Department.
4. The receiving personnel shall check the accompanying documentation (e.g., packing list, bill of lading) against the actual shipment to ensure accuracy.
5. Pharmaceutical products shall be stored in designated quarantine areas until inspection and approval by the QA Department.
6. The QA Department shall conduct a detailed inspection of the received products, including verifying product integrity, expiration dates, and batch numbers.
7. If the products meet the acceptance criteria, the QA Department shall release them from quarantine and update the inventory records accordingly.
8. If any products fail to meet the acceptance criteria, the QA Department shall initiate the appropriate non-conformance procedures.
9. All receiving activities and inspection results shall be documented in the receiving log or electronic system as per company procedures.
10. Upon completion of the receiving process, the Warehouse Manager shall ensure that the received products are stored in the appropriate storage areas following Good Warehouse Practices.

Abbreviations:

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents:

• Receiving Log
• Packing List
• Bill of Lading
• Non-Conformance Report (if applicable)

Reference:

[Regulatory standards, company policies, or industry guidelines as applicable]

SOP Version:

Version 1.0