Monday, 24 June 2019

Use of Hazard Analysis and Critical Control Points (HACCP) for EM locations

In the first part of a review of HACCP methodology (“Use of Hazard Analysis and Critical Control Points (HACCP) - Part 1: Assessing microbiological risks”) the application of HACCP as a tool for conducting microbiological risks assessments was discussed. This piece considered the approach taken to HACCP and the primary areas of microbiological concern to which the qualitative risk tool can be applied to.

This second example offers a case study of how HACCP can be applied to a practical setting: the identification of environmental monitoring locations, by considering, in the HACCP lexicon, monitoring locations as ‘critical control points’.

The selection of appropriate locations for environmental monitoring is a key aspect of any robust environmental monitoring program. If the locations are not in meaningful locations, the strength of the program is undermined. By ‘meaningful locations’ this means locations that reveal, through the data collected, an indication of potential product contamination. Contamination can arise through airborne deposition or by direct transfer, which signals the need for selecting locations that indicate this likelihood and the use of appropriate sampling methods to detect both airborne risks and surface risks (either fixed surfaces, on equipment, or on people). The HACCP approach provides a useful framework for such an assessment.

Tim Sandle’s follow up paper to his first HACCP article has been published. The reference is:

Sandle, T. (2019) Use of Hazard Analysis and Critical Control Points (HACCP) – Part 2: Determining Environmental Monitoring Locations, Journal of GxP Compliance, 23 92): 1-10

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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