Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products

Abstract

Many pharmaceutical or biotechnological products require transport using temperature-controlled systems to keep their therapeutic properties. There are presently no official guidelines for testing pharmaceutical products in order to define suitable transport specifications. After reviewing the current guidance documents, this paper proposes a methodology for testing pharmaceutical products and defining appropriate transport conditions.

Fig. 1

Stability tests during the development of a drug product and those described in ICH guidelines

Fig. 2

Degradation study: example of HPLC traces after 3 and 7 days at +50°C, compared with the initial data

Fig. 3

Transport temperature profiles

Fig. 4

Example showing how to build stability knowledge. a At the beginning. b With the preliminary mathematical model and safety margin. c With the ICH/WHO stability program. d With the preparation/distribution plan. e With a full set of tests

Fig. 5

Example showing how to use the stability knowledge in case of temperature excursions. a With temperature excursion for less than 8 h at 34°C. b With temperature excursion for 10 days at 34°C

Fig. 6

Label of IATA: the exact transport information has to be printed in the white section