Sunday 19 May 2013

Risk Management in Pharmaceutical Microbiology

 Pharmaceutical Manufacturing has published an article by Tim Sandle titled 'Risk Management in Pharmaceutical Microbiology'. The article looks at risk assessment techniques, such as HACCP and FMEA, from a microbiological perspective.

"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.

The article is an edited extract from the book 'Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices', edited  by Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell.

The book can be purchased from Amazon (US) here:

Posted by Tim Sandle

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