Good manufacturing practice- and good distribution practice-compliant cold storage and refrigerated transport of allergen products: what is important?

Abstract

Background: All currently available products for diagnosis and therapy of type I allergies are protein extracts from allergenic source material. The extracted proteins have different properties and their structure is differently labile to temperature variations. Despite various pharmaceutical formulations to increase product stability, with few exceptions, allergen products must be refrigerated to ensure that their quality and native protein structure do not change during storage and transport. Maintaining quality is a challenge in complex distribution chains. Methods: Regulatory requirements and guidelines that apply to cold storage and transport of allergen products are summarized and the responsibilities of the stakeholders are explained. Results: The storage conditions determined in stability studies correspond to the transport conditions. These stability data can also be used to assess tolerable conditions during transport. According to a good distribution practice (GDP) contracts must be concluded between the responsible pharmaceutical entrepreneur and the qualified distribution service provider that regulate storage and transport in accordance with the product requirements. Conclusion: Monitoring of storage and transport conditions is achieved by transport in qualified means of transport (e.g. truck). Alternatively, qualified transport packaging with active or passive cooling (e.g. cold packs) and qualified “data loggers” that record the transport temperatures can be used. Regardless of the system used, it must be demonstrated—by validating the transport conditions, routes and packaging at different times of the year and over the entire duration of transport—that regulatory requirements are met and that the quality of the products is maintained during shipment.