Who good manufacturing practices for sterile pharmaceutical products Introduction

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© World Health Organization

WHO Technical Report Series, No. 961, 2011

Annex 6

WHO good manufacturing practices for sterile 

pharmaceutical products

 Introduction

Following implementation of these WHO good manufacturing practices (GMP) 

guidelines (

1

) within the context of the WHO Prequalifi cation of Medicines 

Programme, clarifying, editorial modifi cations have been proposed.  These 

changes were adopted for maintenance purposes. In order to ease reading the 

full guideline has been reproduced again as an Annex to the current report of 

the WHO Expert Committee on Specifi cations for Pharmaceutical Preparations.