Guide for Recommended Pharmaceutical Product Classification for Transport

The transportation of pharmaceutical products requires strict adherence to regulatory guidelines to ensure their safety, efficacy, and integrity. This document provides a recommended classification system for pharmaceutical products in transit, considering factors such as temperature sensitivity, packaging requirements, and regulatory compliance. Proper classification is essential for minimizing risks associated with degradation, contamination, and improper handling. Pharmaceuticals are categorized based on storage conditions, including ambient, refrigerated, and frozen products, each requiring specific transport protocols. Special attention is given to controlled substances, biologics, and hazardous materials, necessitating specialized packaging and documentation. Compliance with international standards, such as Good Distribution Practices (GDP) and guidelines from organizations like the WHO and FDA, is crucial.

By implementing a standardized classification system, stakeholders—including manufacturers, logistics providers, and regulatory agencies—can ensure efficient and safe pharmaceutical transportation, ultimately protecting patient health and maintaining product quality throughout the supply chain. In the event of appropriate transport not being available, the General Manager (or Quality Assurance Manager) responsible for the dispatch warehouse should be approached. Based upon their knowledge of conditions in the local marketplace and the chosen shipping route, they will decide if the shipment may proceed with additional precautions (e.g., insulated packaging, temperature monitoring, and/or post-delivery testing). If suitable additional precautions are unavailable or impractical, it may be necessary to amend the assigned shelf life of the product. For deliveries to another GSK Local Entity, it is advisable to notify and agree upon these measures with the General Manager (or Quality Assurance Manager) of the receiving entity to avoid rejection upon receipt. Technical Terms of Supply may need to be amended.

Category 1: Protect from Temperatures Above 30°C

No significant problems are anticipated with these products. Although ideally transported below 30°C, short-term exposure to temperatures around 40°C or an average of 35°C for up to four weeks is unlikely to significantly affect the product.

Products in this category include most solid dose forms and liquid products with a 30°C shelf life. Some products with a shelf life greater than two years at 25°C may also fall into this category. Transport labeling should encourage storage away from direct sunlight and other heat sources. Extensive monitoring trials indicate that material exported from the UK has not been exposed to temperatures above 40°C for more than a few hours.

Category 2: Protect from Temperatures Above 25°C

These products are relatively less stable, and exposure to temperatures above 31°C should be avoided. If high-temperature exposure is anticipated, “temperature-controlled” containers should be used, or 31°C Monitor Marks should be included. Any cumulative exposure of more than 72 hours at 31°C should be reported to the Quality Assurance Manager responsible for dispatch for further consideration.

If temperature-controlled containers are unavailable and higher temperatures are likely, air freight should be considered. Surface transport through tropical regions or moderate climates in summer may expose these products to excessive temperatures. Insulating materials or strategic positioning within shipments can help mitigate these risks.

Category 3 & 4: Protection from Freezing

• Category 3: As Category 1 but additionally must not be frozen.
• Category 4: As Category 2 but additionally must not be frozen.

These categories require protection from both high temperatures and freezing. Overland transport lasting more than 24 hours should be avoided in Europe and North America from November to March unless weather conditions indicate that sub-zero exposure is unlikely and appropriate insulation or heating is provided.

In addition to products directly affected by freezing, bulk containers of sterile antibiotics fall under these classifications due to the risk of container seal integrity loss at sub-zero temperatures. Products must not be allowed to freeze. Short-term exposure to temperatures as low as -5°C for a few hours, due to climate or aircraft hold conditions, is unlikely to cause freezing. However, they should be labeled “Do Not Freeze” to prevent improper storage. Creams and sugar-free syrups are particularly vulnerable to freezing damage.

Category 5: Transport at 2°C to 8°C

Products in this category require refrigerated containers for land and sea transport, or air freight with refrigeration (but not deep freeze) at the ports of loading and unloading.

When rapid transit within temperate zones can be guaranteed during cooler months, the use of well-insulated boxes may be sufficient. A 30°C Monitor Mark should be included, and exposure exceeding 24 hours should be reported to the Quality Assurance Manager as required for Category 2 products.

Category 6: Special Requirements

This category applies to products with highly restricted conditions. For example, suppositories must not be exposed to temperatures above 35°C. Special storage solutions and shipping protocols should be implemented to ensure compliance and maintain product efficacy.