Standard Operating Procedure for Distribution Records Management

Purpose

The purpose of this SOP is to establish procedures for the management and maintenance of distribution records within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and facilitating traceability and accountability throughout the distribution process.

Scope

This SOP applies to all personnel involved in the creation, maintenance, and retention of distribution records, including distribution managers, warehouse personnel, and quality assurance professionals.

Responsibilities

• The Distribution Manager is responsible for overseeing distribution records management activities and ensuring compliance with regulatory requirements and company standards.
• The Quality Assurance Manager is responsible for reviewing and approving distribution records and ensuring that records accurately reflect distribution activities and comply with regulatory requirements.
• All personnel involved in distribution activities are responsible for adhering to procedures outlined in this SOP and maintaining accurate and complete distribution records.

Procedure

1. Record Creation:
   • Create distribution records for each shipment or transaction, including information such as product details, quantity shipped, shipping and receiving dates, and destination.
   • Ensure that distribution records are accurately and legibly documented, with all required information recorded in a clear and organized manner.
2. Record Maintenance:
   • Maintain distribution records in a secure and controlled environment, such as a designated record-keeping system or database.
   • Regularly update distribution records to reflect any changes or updates to distribution activities, such as product recalls, returns, or rejections.
3. Record Retention:
   • Establish a record retention policy outlining the retention periods for distribution records based on regulatory requirements and company policies.
   • Ensure that distribution records are retained for the required retention period and disposed of according to established procedures and regulatory guidelines.
4. Record Review and Approval:
   • Review distribution records for accuracy, completeness, and compliance with regulatory requirements before approval by designated personnel, such as the Quality Assurance Manager.
   • Document record review and approval activities, including the names and signatures of personnel responsible for approving distribution records.
5. Record Accessibility:
   • Ensure that distribution records are readily accessible for inspection by regulatory authorities or other authorized parties upon request.
   • Maintain distribution records in an organized and easily retrievable manner, such as by using a centralized record-keeping system or file organization structure.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to distribution records management may include:

• Distribution records
• Record retention policy
• Record review and approval logs
• Regulatory guidelines on record keeping

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0