Tuesday 19 March 2024

Best practices for pharmaceutical microbial data investigations

 Investigating. Image designed by Tim Sandle

Assessing microbiological data and undertaking investigations into the origins of contamination, establishing root causes, and setting appropriate preventative actions constitutes a core part of the contamination control strategy. Despite the importance of this process, regulatory findings frequently cite poor quality microbial investigations.


This article looks at the main steps involved for conducting investigations and provides some best practice advice for the company microbiologist. The goals here are to help to structure investigations that are:


  • Simple:            Easy to execute and to understand,
  • Effective:        Producing the correct result.


The advice is presented as a series of phases. While the phases represent activity blocks, they should not necessarily be thought of as discrete entities for they can run concurrently or may overlap. This is especially useful in order to complete a detailed and thorough investigation within a reasonable timeframe (as with other investigations undertaken within pharmaceuticals, a target of 30 days is often applied).


Sandle, T. (2023): Assessing microbial contamination: Best practices for pharmaceutical microbial data investigations, American Pharmaceutical Review, 26 (3): 20-26: https://www.americanpharmaceuticalreview.com/Featured-Articles/596293-Assessing-Microbial-Contamination-Best-Practices-for-Pharmaceutical-Microbial-Data-Investigations/?cid=26759

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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