Monday, 6 January 2020

Use of Hazard Analysis Critical Control Point (HACCP) methodology for biocontamination control

The concept of Hazard Analysis and Critical Control Points (HACCP) methodology is a system that enables the production of safe products, be they pharmaceuticals or health care products and devices or, as with the origins of HACCP, food. HACCP is an example of a risk assessment tool, and the use of risk assessment, especially proactive risk assessment, is encouraged by regulators as part of Quality Risk Management philosophies.

In terms of applying HACCP to environmental monitoring, a new peer reviewed paper of interest, from Tim Sandle and colleagues, has been published. Here is the abstract:

Quality Risk Management has been an essential feature relating to the manufacture of pharmaceutical and healthcare products for several decades, and its centrality is embedded in key regulatory documents, such as Annex 1 to EU GMP where risk assessment needs to be part of the overall biocontamination control strategy. While the message for constructing pro-active risk assessment sis clear, where the industry lacks direction is with case studies. This paper presents one risk assessment tool, and one which is perhaps best suited to microbiological assessments of pharmaceutical processes and presents a case study for its application. The tool discussed is Hazard Analysis and Critical Control Points (HACCP) and the application is with assessing microbiological risks and then establishing locations for environmental monitoring. The case study is a sterility testing isolator. The paper first discusses what HACCP is and how it can be applied in general, before demonstrating how HACCP can be deployed as a robust tool for constructing or reviewing an environmental monitoring regime.

The reference is:

Sandle, T., Di Mattia, M., and Leavy, C. (2019) Use of Hazard Analysis Critical Control Point (HACCP) methodology for biocontamination control: Assessing microbial risks and to determining environmental monitoring locations, European Journal of Parenteral and Pharmaceutical Science, 24 (3): 1-36 (link:

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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