Search results with tag "Stability data package"
Annex 2 Stability testing of active pharmaceutical ...
www.ich.org88 1. Introduction 1.1 Objectives of these guidelines These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredients (APIs) and
STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
www.who.intWorking document QAS/17.694 page 3 Introduction and background36 37 38 The Stability testing of active pharmaceutical ingredients and finished 39 pharmaceutical products was published as Annex 2 in the WHO Technical 40 Report Series, No. 953, 2009 (1). 41 42 These regulatory guidelines seek to exemplify the core stability data package 43 required for …
STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
www.who.intWorking document QAS/17.694 page 6 1.141 Introduction 142 1.1 Objectives of these guidelines 143 These guidelines seek to exemplify the core stability data package 144 required for registration of active pharmaceutical ingredients (APIs) and 145 finished pharmaceutical products (FPPs), replacing the previous WHO 146 guidelines in this area (1).