The International Conference on Harmonization (ICH) Tripartite Guideline "Stability Testing of New Drug Substances and Products" sets out the stability testing requirements for a registration application within the three areas of the European Union, Japan, and the United States. These areas are assigned to climatic zone II with the storage condition of 25 degrees C/60% RH. This paper describes the adjustments that are necessary to extend the guideline to countries of climatic zones III and IV. At first storage conditions were derived with 30 degrees C/35% RH for climatic zone III and 30 degrees C/70% RH for climatic zone IV. Both conditions contain a margin of safety compared to calculated and measured data in warehouses. Furthermore, they cover the extreme temperatures above 30 and 40 degrees C which may arise in these climatic zones. Six months at 40 degrees C/75% RH was fixed as storage condition for accelerated testing to assess organoleptic and physicochemical test criteria and to make predictions for chemical stability. The predictive factor is 3.3 for 30 degrees C (6 months at 40 degrees C corresponds to 20 months at 30 degrees C). Extreme temperatures which may arise during shipment are covered by the results of stress investigations (e.g., 3 months at 50 degrees C). The next adjustment is necessary for the selection of the packaging containers. They must reflect the requirements for solid, semisolid, and liquid dosage forms caused by the two storage conditions. In the evaluation the temperature difference of 10 degrees C (40-30 degrees C) instead of 15 degrees C has to be considered, which limits the preliminary shelf lives in critical cases to 18 months instead of 24 months. Finally, statement/labeling must reflect the storage conditions. All of the other basic principles for the drug substances and drug products, such as selection and number of batches, test criteria, test procedures, specifications, testing frequency, and storage period can be applied without any change.

Summary Product takeback calls for sound strategies of product recovery management One such strategy‐is the reuse of the components of a product. There are consumer products such as power tools whose most expensive component, the electric motor; offers potential for reuse. Empirical evidence reveals that the lifetime of a motor often exceeds the life‐time of the product using it. This article focuses on the reuse of electric motors. For this purpose, a novel circuit was developed that measures, computes, and records parameters strongly correlated with the degradation of a motor during the use stage of the product. This circuit, called electronic data log (EDL), provides valuable insights into the usage patterns of products. The data recorded during the use stage are retrieved after product takeback as a basis for reuse decisions. In this article, the trade‐off between higher initial manufacturing cost caused by the EDL and cost savings from the reuse of used motors is analyzed. The problem of misclassifications of used motors is also addressed. It is shown that the return rate of used products is the critical parameter determining the economic efficiency of a motorreuse strategy based on EDLs. The analysis shows that the implementation of EDLs in products as an enabler for motor reuse may be associated with large cost savings

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