WHO TRS (Technical Report Series) 953, 2009 Annex 4
Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products
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TABLE OF CONTENTS
1. Introduction
A significant part of the quality of a finished pharmaceutical product (FPP) is dependent on the quality of the active pharmaceutical ingredients (APIs) used for its production. Under the World Health Organization (WHO) guidelines on good manufacturing practices (GMP), it is the manufacturer of the FPP who is responsible for the overall quality of the product, i.e. including the choice of the suppliers and manufacturers of the ingredients.
WHO TRS (Technical Report Series) 953, 2009 Annex 4
