NABP Temperature Validation Studies

Written-by: Sumeet Singh, CEO

For all entities that are applying for NABP’s Drug Distributor Accreditation, or are currently accredited, did you know NABP requires the use of validated shipping containers or temperature indicators for all temperature-sensitive prescription drug products? The NABP typically conducts these validation studies twice a year during the Summer and Winter.

The best time to conduct a summer temperature validation study is coming up next month, July.

Why Validation is Necessary

The purpose of this validation is to ensure that temperature-sensitive products shipped from your facility maintain the proper temperature range to product integrity for the duration of shipping until the product is received by the customer.

The recommendation would be to then repeat this validation again in 3-5 years. Are you prepared for this and other NABP DDA standards? Find out how we can help prepare you for temperature validation studies, click here to contact us.

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