The 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 guidelines. It 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 re-evaluation. The 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. As a result, the ICH parties withdrew one of their guidance texts (Q1F) and published the following text on their website:
Access to Medicines and Health Products (MHP), Health Product Policy and Standards (HPS), Norms and Standards for Pharmaceuticals (NSP), Technical Standards and Specifications (TSS)