Quality Risk Management of Microbial Burden in Parenteral API Production Processes

This paper describes a risk assessment technique that may be used to control bioburden in parenteral active pharmaceutical ingrethent (API) production processes. Readers can use the risk assessment technique to achieve bioburden control during API processing. The objective in creating this tool was...

Full description

Saved in:
Bibliographic Details
Published in:Journal of GXP compliance 2011-07, Vol.15 (3), p.75
Main Authors: Herz, Herman, Bache, Anne-Lise, Holst, Birgitte
Format: Article
Language:English
Subjects:
Biotechnology
Good Manufacturing Practice
Ingredients
Manufacturers
Manufacturing
Microbiology
Pharmaceutical industry
Pharmaceuticals
Quality control
Raw materials
Risk assessment
Variables
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:This paper describes a risk assessment technique that may be used to control bioburden in parenteral active pharmaceutical ingrethent (API) production processes. Readers can use the risk assessment technique to achieve bioburden control during API processing. The objective in creating this tool was to develop a way to establish a balanced control strategy regarding bioburden. [PUBLICATION ABSTRACT]
ISSN:1552-5791
2150-6590