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:
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: https://phss.preview.foleon.com/publications/ejpps-2019-vol243/use-of-hazard-analysis-critical-control-point-haccp-methodology-for-biocontamination-control-assessing-microbial-risks-and-to-determining-environmental-monitoring-locations/)
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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