ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products.Good Manufacturing Practices: Temperature Mapping of Controlled Temperature Chamber.EU Guidelines in Good Distribution Practice of medicinal products for human use.961: Temperature mapping of storage areas. Influencing factors considered during mapping Various guidelines exist as to why temperature mapping is required and how it should be carried out: Environmental monitoring systems can be installed to ensure that the area complies to the defined temperature limits to ensure patient safety. Further to a mapping study, the design of an area may be improved or simply blocked off for any GxP purpose.

This must be avoided under all circumstances and steps taken immediately in the case of unintended changes in climatic conditions! Temperature mapping is a study, where the temperature distribution within an area is studied, documented and analysed.įor applications that are subjected to the GxP quality guidelines within regulated industries, mapping is essential to decide where, within an area, testing, production, storage and distribution can be carried out based upon a scientific risk-based assessment, using the results from a mapping study. Incorrect temperature or humidity measurements can result in expensive damage to products. Downloads Archive (End Of Life Products).

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