Transcription of Annex 10 - ICH
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Annex 10 - ICH
309 Annex 10 stability testing of active pharmaceutical ingredients and finished pharmaceutical productsIntroduction and backgroundThe guidance on stability testing of active pharmaceutical ingredients and finished pharmaceutical products was published as Annex 2 in the World Health Organization (WHO) Technical Report Series, No. 953, 2009 (1).The aim of these regulatory guidelines is to outline the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), replacing the previous WHO guidelines in this area. The guidelines cross-refer to the series of related documents published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (2) and other WHO was recommended that at the time of their publication these guidelines should also be applied to products that are already being marketed, making allowance for an appropriate transition period, for example, they could become applicable upon re-registration or upon 2009 guidance not only followed the usual consultation process, but it was also the result of numerous discussions with the various regulatory forums, including ICH.
should be derived from stability testing data. 2.1.2 Stress testing Stress testing of the API can help identify the likely degradation products, which in turn can help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability-indicating power of the analytical procedures used.
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