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.
Annex 10 311 1. Introduction 312 1.1 Objectives of these guidelines 312 1.2 Scope of these guidelines 312 1.3 General principles 312 2. Guidelines 313 2.1 Active pharmaceutical ingredient 313 2.1.1 General 313 2.1.2 Stress testing 313 2.1.3 Selection of batches 314 2.1.4 Container-closure system 314 2.1.5 Specification 315 2.1.6 Testing frequency 315 2.1.7 Storage …
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