Quality Risk Management and Environmental Monitoring

Cleanrooms in which biotechnology pharmaceutical processing takes place are subject to environmental monitoring. The frequency at which such monitoring should be performed can be difficult to determine. This paper uses quality risk assessment methods to construct a framework for determining monitoring frequencies and illustrates the suitability of the framework through a case study.

The above refers to a PDA Journal paper written by Tim Sandle, concerning the application of Quality Risk Management to environmental monitoring.

Here is the abstract:

“Environmental monitoring programs are essential for pharmaceutical facilities in order to assess the level of environmental control. For biotechnology facilities there is little advice as to the frequency at which viable environmental monitoring should be conducted. This paper outlines an approach, based on the principles of quality risk management, for the development of a framework from which monitoring frequencies can be determined. This involved the identification of common hazards and the evaluation those hazards in terms of the severity of contamination and the probability of contamination occurring. These elements of risk were evaluated for different cleanrooms and the relative risks ranked. Once the risk scores were calculated, the methods for detecting risks within the cleanrooms were assessed. Risk filtering was then used to group different cleanrooms based on their relative risks and detection methods against predetermined monitoring frequencies. Through use of case study examples, the paper presents the model and describes how appropriate frequencies for the environmental monitoring of cleanrooms can be set.”

The reference is:

Sandle, T. (2012) Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas, PDA Journal of Pharmaceutical Science and Technology November/December 2012 vol. 66 no. 6 560-579

For further details, see PDA.

Posted by Tim Sandle