Standard Operating Procedure for Receiving and Acceptance of Goods

Purpose

The purpose of this SOP is to establish procedures for the systematic and accurate receipt and acceptance of pharmaceutical goods, ensuring compliance with Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel involved in the receiving, inspection, and acceptance of pharmaceutical goods at the receiving facility.

Responsibilities

• The Receiving Department is responsible for receiving, inspecting, and documenting incoming pharmaceutical goods.
• The Quality Assurance (QA) Department is responsible for verifying the compliance of received goods with established specifications and regulatory requirements.
• The Warehouse Management Team is responsible for storing received goods in appropriate conditions and locations.

Procedure

1. Receipt of Goods:
   • Receive goods from suppliers or carriers at the designated receiving area.
   • Verify the accuracy of shipment documentation, including packing lists, invoices, and certificates of analysis.
2. Physical Inspection:
   • Inspect incoming goods for any visible damage, contamination, or discrepancies with purchase orders.
   • Check for proper packaging and labeling in accordance with regulatory requirements.
3. Temperature Control:
   • Monitor and record temperature conditions of temperature-sensitive products during transit and upon receipt.
   • Reject goods that do not meet specified temperature requirements or show signs of temperature abuse.
4. Sampling and Testing:
   • Collect samples of incoming goods as per sampling plans and procedures.
   • Perform visual inspections, physical tests, or laboratory analyses to verify product quality and compliance.
5. Documentation and Recordkeeping:
   • Document all received goods, inspection results, and acceptance decisions in receiving records or electronic systems.
   • Maintain traceability of received goods through unique identifiers, lot numbers, or batch numbers.
6. Acceptance or Rejection:
   • Accept goods that meet established specifications and quality standards.
   • Reject goods that fail to meet acceptance criteria and initiate appropriate actions, such as return to supplier or quarantine.

Abbreviations

• QA – Quality Assurance
• GDP – Good Distribution Practice

Documents

Reference documents related to receiving and acceptance of goods may include:

• Standard operating procedures (SOPs)
• Receiving logs or records
• Quality control specifications
• Temperature monitoring records
• Supplier certificates of analysis

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0