Stability testing of (api) active pharmaceutical ingredients and finished pharmaceutical products - Annex 10
Introduction and background
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.
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TABLE OF CONTENTS
1.1 Objectives of these guidelines
2.1 Active pharmaceutical ingredient
2.1.4 Container-closure system
2.1.10 Statements and labelling
2.1.11 Ongoing stability studies
2.2 Finished pharmaceutical product
2.2.4 Container-closure system
2.2.10 Statements and labelling
2.2.11 In-use and hold time stability
2.2.13 Ongoing stability studies
Appendix 1 Examples of testing parameters
Appendix 2 Recommended labelling statements
WHO TRS (Technical Report Series) 1010, 2018 Annex 10