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
- Rapid Microbiology Methods
About the Editors
Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group TM, and is a member of ASQ and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished Editor/Author Award.
Karen Zink McCullough, is principal consultant at MMI Associates, a consulting firm specializing in Endotoxin and Microbiology testing compliance. Ms. McCullough has over 35 years of experience in the Bacterial Endotoxins Test, and was the first to publish on the use of the LAL test for release of small volume parenterals. She teaches globally on Endotoxin and microbiological testing. Her current interest is the use of the BET assay as a tool for process control. She is a charter member and current Chair of the LAL Users' Group, a member of the United States delegation to TC209, WG02, ISO 14698 (Biocontamination) standard revision, and also a member of the Microbiology General Chapters Expert Committee of the United States Pharmacopeia.