Monday, 15 October 2018

Use of Hazard Analysis and Critical Control Points (HACCP) - Part 1: Assessing Microbiological Risks


Environmental monitoring is an important part of a biocontamination control strategy in a pharmaceutical or healthcare organization. Monitoring is undertaken in order to assess if controlled areas are operating as designed and to assess the risk of microorganisms to pharmaceutical products, in terms of contamination transfer. Monitoring data is assessed against assigned limits (or frequencies) and by assessing the collected data over time in the form of trend analysis. Importantly, environmental monitoring is used to confirm that sufficient controls are in place; in itself it cannot be used as a substitute for control.


There are several aspects to environmental monitoring and each aspect must be described in an environmental monitoring program; such elements include method selection, determining frequencies of monitoring, locations for sampling, selection of culture media, choice of data analysis tools and so on. This article looks at one of these aspects: determining the locations for monitoring and here a risk assessment tool can be applied for this purpose: Hazard Analysis and Critical Control Point (HACCP).

For pharmaceuticals and healthcare there are a myriad of different risk assessment tools available, some of which are of more use than others (and of these more useful approaches, some are easier to understand and implement). The foremost risk assessment tool in pharmaceuticals appears to be Failure Modes and Effects Analysis (FMEA). While FMEA has many uses, especially for deconstructing equipment to try and to detect points of failure (‘failure modes’) it is perhaps less suited for following a process flow. This is where HACCP has its advantages. Unlike FMEA, which uses risk scoring based on an ordinal number concept, HACCP is a qualitative risk assessment tool.


HACCP is a risk assessment approach, originating in the food industry that can be used to assess physical, chemical, and biological hazards. HACCP is designed in such as way so that the potential hazards, or points of potential failure (or in the case of environmental monitoring – contamination) that can occur are identified. Hence HACCP is a pro-active tool, consisting of a preventive approach to identify hazards throughout a process.


The locations where potential hazards can occur are, within the HACCP lexicography, known as Critical Control Points (CCPs). At these identified points actions can be taken to reduce or eliminate the risk of the hazards being realized. HACCP involves focusing on where the most important control points in a process are and, where risks remain, undertaking monitoring. Once these monitoring locations are established critical limits are to be set. The monitoring to critical limits enables the process to be verified as being in control (or not). The output is a documented plan to control these scenarios.

This article discusses the concept of risk and the basis of HACCP. A follow up article (part B) looks at an example of environmental monitoring location determination using HACCP methodology.


The reference is:

Sandle, T. (2018) Useof Hazard Analysis and Critical Control Points (HACCP) - Part 1: AssessingMicrobiological Risks, Journal of GxP Compliance, 22 (4): 1-12

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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