A new book of interest. PDA / DHI have issued ‘Microbial Risks and Investigations’, edited by Jeanne Moldenhauer, Karen McCullough.
The
Barr Decision (Barr, 1993) forever changed how pharmaceutical companies look at
data that is out-of-specification (OOS). Following issue of this legal
decision, many companies and regulators worked to determine how this decision
affects microbiological test results.
Microbial
Risk and Investigations, written by authors with years of industry experience
and edited by industry experts Jeanne Moldenhauer and Karen Zink McCullogh,
provides a wealth of information on microbial investigations and dealing with
aberrant data. Many of the chapters include case studies that can provide
guidance for common situations that may occur at your facility.
Some
of the many topics covered include:
- Types of Investigations
- The Microbiologist's Tool Box
- Quality Metrics
- Contamination Risk Evaluation
- Sterility Testing
- Objectionable Organisms
- Particulates
- Rapid Microbiology Methods
The
book contains two chapters by Tim Sandle, these are:
Sandle,
T. (2015) Investigating Sterility Test Failures. In McCullough, K.Z. and
Moldenhauer, J. (Eds.) Microbial Risks
and Investigations, DHI/PDA, River Grove, USA, pp261-290
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources