Monday 7 February 2022

Release of sterile medicinal products– looking at the focal points


This article looks at some of the focal points required for the quality assurance assessment of sterile products. This is a large subject area and one where additional variations are introduced, according to product types, meaning that only broad themes can be discussed. Two of the central themes underpinning sterility assurance are a science based holistic contamination control strategy and a mature quality culture that places proactive risk assessment at the forefront.

There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.

Sandle, T. (2021) Release of sterile medicinal products– looking at the focal points, European Pharmaceutical Review, Future of QA/QC for Complex Biologics White Paper, pp11-15:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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