Standard Operating Procedure for Batch Traceability

Purpose

The purpose of this SOP is to establish procedures for tracing batches of pharmaceutical products throughout the warehouse to ensure product quality, integrity, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in handling, storing, and distributing pharmaceutical products within the warehouse.

Responsibilities

• Warehouse Manager: Overall responsibility for implementing batch traceability procedures and ensuring compliance.
• Inventory Managers: Responsible for maintaining accurate batch records and overseeing traceability processes.
• Warehouse Staff: Responsible for recording batch information and facilitating traceability activities.
• Quality Assurance: Responsible for verifying batch traceability and conducting audits to ensure compliance.

Procedure

1. Batch Identification:
   • Assign unique batch numbers or identifiers to incoming pharmaceutical products upon receipt.
   • Record batch information, including production dates, expiration dates, and lot numbers, in batch records or electronic systems.
   • Label products with batch information for easy identification and traceability throughout the warehouse.
2. Batch Tracking:
   • Track the movement of batches throughout the warehouse using batch records, inventory management systems, or barcode scanning.
   • Record batch transactions, including receipts, transfers, picking, packing, and shipping activities, to maintain traceability.
   • Implement procedures to reconcile batch records with physical inventory regularly to identify discrepancies and ensure accuracy.
3. Batch Recall and Retrieval:
   • Establish procedures for batch recall and retrieval in the event of quality issues, safety concerns, or regulatory requirements.
   • Maintain up-to-date records of batch locations and distribution channels to facilitate timely recall actions.
   • Coordinate with relevant stakeholders, including suppliers, customers, and regulatory authorities, to initiate batch recalls as needed.
4. Batch Documentation:
   • Maintain accurate and complete batch documentation, including batch records, certificates of analysis, and manufacturing documents.
   • Ensure that batch documentation is readily accessible for review by authorized personnel and regulatory inspectors as needed.
   • Archive batch documentation according to established retention periods and document control procedures.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Batch Records
• Batch Recall Procedures
• Batch Documentation Checklist
• Batch Traceability Audit Reports

SOP Version

Version 1.0