Monday 31 May 2021

An Anatomy Of A Contamination Control Strategy For Sterile Manufacturing


A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event).

It is recognized that any contamination control strategy represents a cyclical process, designed to prompt the manufacturers to identify and resolve risk, and hence one that requires periodic review and update. While contamination control strategies are foremost discussed in relation to sterile manufacturing, most of the elements are applicable to non-sterile processing as well.

This article, in considering the key features and components, presents an anatomy of a contamination control strategy. This primarily in relation to sterile manufacturing (although there will no doubt be elements of interest to non-sterile manufacturers). The aim is to provide a framework that can be used by pharmaceutical and healthcare organizations for benchmarking purposes.

The reference is:

Sandle, T. (2021) An Anatomy Of A Contamination Control Strategy For Sterile Manufacturing, Journal of GxP Compliance, 25 (2):

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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