Who good manufacturing practices for sterile pharmaceutical products Introduction

Further reading

 

FDA Guidance for Industry. 

Sterile drug products produced by aseptic 

processin g — cGMP. 

US Food and Drug Administration, 2004.

 

Guidance for industry. 

Sterile drug products produced by aseptic 

processing

. Japan, 2005.

Manufacture of sterile medicinal products. In:

 The rules governing medicinal 

products in the European Union Vol. 4. EU guidelines to good manufacturing 

practice medicinal products for human and veterinary use

. Annex 1, Brussels, 2008.