meet the principles for product stewardship and ensure long-term sustainability.
To further ensure sustainability and
protection for workers, patients and the
public, the U.S. Food and Drug Administration (FDA) and its equivalent agencies
worldwide are evaluating a process called
Risk-MaPP. This program, developed by
the International Society of Pharmaceutical Engineers and titled ISPE Baseline®
Guide Volume 10: Risk-Based Manufacture of Pharmaceutical Products (
Risk-MaPP), is designed specifically for
pharmaceutical manufacturing and processing environments. Regardless of its
initial purpose, it can be adapted and utilized for risk assessments across all industries and is specific for highly potent and
hazardous compounds. As a result, it fits
well with the rigors of nanotechnology.
The guide itself provides a step-by-step
rationale for conducting science-based
risk assessments and is useful for assessing compounds on a case-by-case basis.
Be wary, however: Risk-MaPP is a method
of Failure Mode and Effects Analysis
INSIGHT | DEPARTMENT
(FMEA) and is not designed for conducting rapid evaluations. It includes extreme
detail as a part of the process and yields a
highly quantitative assessment.
Implications and Opportunities for
As leading practitioners and participants
in the industrial hygiene community, we
can all be part of the solution for sustained development of safe nanotechnology. I encourage industrial hygienists to
participate in the AIHA Nanotechnology
Working Group. For more information,
(505) 923-1320 or Donald.Ewert@osobio.com.
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