Standard Operating Procedure for Good Distribution Practices (GDP) Compliance

1) Purpose

This SOP outlines the procedures for ensuring compliance with Good Distribution Practices (GDP) to maintain the integrity, quality, and safety of pharmaceutical products throughout the distribution chain.

2) Scope

This SOP applies to all personnel involved in the storage, distribution, transportation, and handling of pharmaceutical products, including warehouse staff, logistics personnel, and distributors.

3) Responsibilities

The Distribution Manager or designated personnel are responsible for overseeing GDP compliance. Warehouse managers, distribution supervisors, and quality assurance personnel are responsible for implementing GDP requirements in their respective areas.

4) Procedure

4.1 Storage Conditions

1. Store pharmaceutical products under appropriate conditions of temperature, humidity, and light according to manufacturer specifications and regulatory requirements.
2. Monitor and record storage conditions regularly, including temperature and humidity monitoring.

4.2 Inventory Management

1. Establish inventory management procedures to ensure accurate receipt, storage, picking, and dispatch of pharmaceutical products.
2. Implement first-in, first-out (FIFO) and first-expiry, first-out (FEFO) principles to minimize product expiry and obsolescence.

4.3 Handling and Transportation

1. Handle pharmaceutical products with care to prevent damage, contamination, or mix-up during loading, unloading, and transportation.
2. Ensure transportation vehicles and containers are clean, secure, and suitable for the transport of pharmaceutical products.

4.4 Documentation and Record Keeping

1. Maintain accurate and complete documentation of all distribution activities, including receipt records, shipping records, and temperature excursion reports.
2. Ensure proper documentation of product returns, recalls, and destructions as per established procedures.

4.5 Quality Assurance

1. Perform regular quality audits and inspections of distribution facilities, procedures, and documentation to verify compliance with GDP requirements.
2. Implement corrective and preventive actions (CAPA) for identified non-conformities and deviations.

4.6 Security and Theft Prevention

1. Implement security measures to prevent unauthorized access, theft, or tampering of pharmaceutical products during storage and distribution.
2. Ensure all personnel are trained on security procedures and adhere to access control measures.

4.7 Product Recall and Returns

1. Establish procedures for initiating and managing product recalls and returns, ensuring timely communication with relevant stakeholders and regulatory authorities.
2. Conduct mock recall exercises periodically to test the effectiveness of recall procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GDP: Good Distribution Practices
FIFO: First-In, First-Out
FEFO: First-Expiry, First-Out
CAPA: Corrective and Preventive Actions

6) Documents, if any

GDP Compliance Checklist, Temperature Monitoring Records, Inventory Management Logs, Distribution Records, Quality Audit Reports, Product Recall Plans, Security Incident Reports

7) Reference, if any

Regulatory guidelines such as WHO Good Distribution Practices for Pharmaceutical Products, EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use, FDA Current Good Distribution Practices (CGDP) for Finished Pharmaceuticals (21 CFR Part 211)

8) SOP Version

Version 1.0