A temperature mapping study is performed in line with Guidelines on Good Distribution Practice of medicinal products for human use to generate a temperature profile of to ensure that facilities, units, trailers etc. are capable of maintaining the required product storage temperatures and to determine the placement of the continuous monitoring sensors.
GDP Guidelines 2013/C 343/01
“Guidance for Industry Part 11, Electronic Records, Electronic Signatures Scope and Application"
Global Standard for Storage and Distribution
Supplement 11 – Qualification of refrigerated road vehicles (Technical supplement to WHO)
Good storage and distribution practices for medical products, Annex 7.
“Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances”, IA-G0011-1
Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Best Practice on Transport Qualification: Good Distribution Practice, BioPhorum.
“Guide on Wholesaling of Medicinal Products for human use in Ireland”
Global Standard for Food Safety
Annex 9 - Model guidance for the storage and transport of time- and temperature– sensitive pharmaceutical products (World Health Organization (WHO))
Temperature conditioned transport equipment used for the distribution of pharmaceutical products (for human beings or veterinary use). Guidelines for qualification
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