“Within microbiology, a shift is taking place from simple laboratory studies toward greater use of risk assessment and management. Sometimes these approaches form part of a drug company’s total quality system, sometimes they exist as standalone techniques. The most important guidelines for pharmaceutical microbiology are described in ICH Q9, including the tools of FMEA (Failure Mode and Effects Analysis); FTA (Fault Tree Analysis); and HACCP (Hazard Analysis Critical Control Points).
The two most commonly used within microbiology are HACCP (which originated in the food industry) and FMEA (which was developed for the engineering industry). This article explores these two approaches, first with a description of HACCP, followed by a description and case study of FMEA in sterility testing.”
The article can be found here, and the reference is:
Sandle, T. (2012). “Risk Management in Pharmaceutical Microbiology: at look at how HACCP and FMEA can make a difference in the pharma micro lab.”, Pharmaceutical Manufacturing Magazine on-line
See Tim Sandle’s new guide to risk management for the pharmaceutical industry here: http://www.amazon.com/Management-Assessment-Pharmaceutical-Manufacturing-ebook/dp/B00BIHZWBQ/ref=sr_1_6?s=books&ie=UTF8&qid=1366562326&sr=1-6&keywords=tim+sandle