Good manufacturing practice- and good distribution practice-compliant cold storage and refrigerated transport of allergen products: what is important?
نویسندگان
چکیده
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 their structure is differently labile to temperature variations. Despite various pharmaceutical formulations increase product stability, with few exceptions, allergen must be refrigerated ensure that quality native do not change during storage transport. Maintaining a challenge in complex distribution chains. Methods Regulatory requirements guidelines apply cold transport summarized the responsibilities stakeholders explained. Results conditions determined stability studies correspond conditions. These data can also used assess tolerable According good practice (GDP) contracts concluded between responsible entrepreneur qualified service provider regulate accordance requirements. Conclusion Monitoring achieved by means (e.g. truck). Alternatively, packaging active or passive cooling packs) “data loggers” record temperatures used. Regardless system used, it demonstrated—by validating conditions, routes at times year over entire duration transport—that regulatory met maintained shipment.
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ژورنال
عنوان ژورنال: Allergo journal international
سال: 2021
ISSN: ['2197-0378']
DOI: https://doi.org/10.1007/s40629-021-00193-3