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.
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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