Guide for Pharmaceutical Product Classification for Warehousing

Introduction

Effective warehousing of pharmaceutical products is critical to maintaining their quality, safety, and regulatory compliance. This guide provides a structured classification system to ensure proper storage, handling, and inventory management of pharmaceutical products within warehouses. Proper classification minimizes risks related to contamination, degradation, and regulatory non-compliance.

Pharmaceutical products are categorized based on factors such as temperature requirements (ambient, refrigerated, or frozen), stability, and regulatory status. Special attention is given to controlled substances, hazardous materials, and biologics, which require secure storage and strict documentation. Adherence to Good Storage Practices (GSP) and guidelines from regulatory authorities such as the WHO, FDA, and EMA ensures compliance and product integrity.

By implementing a standardized classification system, warehouses can optimize space utilization, improve operational efficiency, and enhance traceability. This guide serves as a valuable resource for pharmaceutical manufacturers, distributors, and logistics providers in maintaining a safe and efficient supply chain.

Product Storage Categories

Category A

Store below 30°C (including products with 25°C life of same duration)

• Applies to the majority of products.
• Includes those with a life of 30°C only and those with identical lives at 30°C and 25°C.

Category B

Store below 25°C or Store below 30°C

• Applies to temperature-sensitive products.
• Products have the option of a longer life below 25°C or a shorter life below 30°C.
• If labelled “store below 25°C,” these must be stored below this temperature.

Category C

Store below 25°C

• Applies to products with a life allocated only for storage at up to 25°C.

Category D

Store below 25°C but at 2°C to 15°C when possible

• Applies to some products labelled “store below 25°C.”
• When possible, store cool (below 15°C) or in a refrigerator for optimal condition.
• Mainly applies to certain bulk antibiotics.

Category E

Store 2°C to 8°C

• Refrigerated storage is required for these products.

Category F

Special storage requirements apply

• The specific requirements of these products or materials are not covered by the above categories.
• Refer to the product-specific MTD or list of storage and transport conditions.

Conclusion

Proper warehousing and storage conditions are crucial for maintaining product quality and compliance. Following the recommended classification ensures optimal shelf life, safety, and effectiveness of stored products.