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Enhance Your Understanding of GDP Requirements with External Training!

Here’s a closer look:

Key GDP Requirements for Warehouses:

Licensing and Compliance

• Warehouses must obtain licenses from relevant health authorities.
• Storage conditions, such as temperature, must align with GDP guidelines (GDP 2013/C 343/01 for human medicines and REGULATION (EU) 2021/1248 for veterinary medicines).
• API’s – often forgotten – handling needs to be compliant with guidelines of 19 March 2015 for human API and Reg 2021/1280 for veterinary API.

Quality Management System (QMS)

• Maintain a robust QMS with documented Standard Operating Procedures (SOPs) covering all warehousing and distribution activities. It’s important that forms are easy to use, to ensure your daily operations go smoothly.
• Include records for temperature monitoring, stock management, and product handling.
• Implement robust procedures for managing defective products, temperature excursions, picking, scanning of the Unique Identifier,….

Training

• Ensure all personnel are trained in GDP with regular refresher courses. These training should include falsification awareness.

Premises and Equipment

• Use appropriate premises and equipment to maintain the quality and safety of stored medicines and APIs.
• Monitor temperature conditions using calibrated equipment. Ensure warehouse is clean by implementing a cleaning plan.

Security and Stock Management:

• Implement controlled access to secure the premises against unauthorized entry and theft.
• Organize the premises to ensure proper segregation of products (e.g., quarantined, rejected, returned, or recalled products) to avoid mix-ups.
• Maintain a precise inventory control system and use a first-expiry, first-out (FEFO) method to manage stock rotation.

Risk Management and Continuous Improvement:

• Regularly assess risks related to storage and distribution, including temperature excursions, theft, and contamination.
• Apply Corrective and Preventive Actions (CAPAs) for any deviations from GDP.
• Conduct audits of subcontractors and perform self-inspections to ensure ongoing compliance.
• Update practices to align with new regulations, technologies, or audit findings.

By adhering to these GDP principles, warehouses can safeguard the efficacy and safety of medicines throughout the distribution process, thereby protecting public health and ensuring regulatory compliance.