Monday, 6 July 2015

Microbial Risks and Investigations


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

Sandle, T. (2015) Contamination Control Risk Assessment. In McCullough, K.Z. and Moldenhauer, J. (Eds.) Microbial Risks and Investigations, DHI/PDA, River Grove, USA, pp783-836

Posted by Tim Sandle