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The purpose of stability controls is to investigate how a pharmaceutical product or active ingredient might change under certain environmental conditions (e.g. temperature, humidity or illumination) during a defined period of time.
The study results are used to define the expiry date and the storage recommendations for an API or drug. For stability controls the conditions and duration of storage, the testing intervals, the number of batches investigated and the packaging materials used depend on the stage of development of the drug concerned and vary according to the climatic zones in the countries of distribution.
Separate guidelines regulate stability controls if the product or the production process is changed or if multi-dose containers are examined for in-use stability after they have been opened.
The analytical methods used in these stability controls must be validated according to ICH guidelines at the latest before the beginning of clinical studies.
These topics are discussed in an article written by Rainer Walz and Martin Knauf of UFAG LABORATORIEN AG which appeared in the magazine section “Wissenschaft + Technik” of the current edition of pharmind 9/2008.
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