Tag Archive for nonsterile

The Compendial Draft Chapter on “Bioburden Control of Nonsterile Drug Substances and Products”

USP Chapter 1115 Pharm Forum 39(4) July/August 2013.

Scott Sutton, Ph.D.
Microbiology Network, Inc.

 

The long-awaited USP draft of a newly proposed chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products” has been released in Pharmacopeial Forum of July/August, 2013.   This chapter describes a risk-based approach to monitor and control of the manufacturing facility and process for non-sterile drugs. Read more