Risk-MaPP Quality & IH Implications. Robert Sussman, Ph.D., DABT Managing Principal, Eastern Operations John P. Farris, CIH President & CEO Pharmaceutical IH Forum – May 18, 2011 Some slides courtesy of ISPE and PharmaConsult US. SafeBridge Consultants, Inc. Product Quality Applications.
Quality & IH Implications
Robert Sussman, Ph.D., DABT
Managing Principal, Eastern Operations
John P. Farris, CIH
President & CEO
Pharmaceutical IH Forum – May 18, 2011
Some slides courtesy of ISPE and PharmaConsult US
SafeBridge Consultants, Inc.
Systematic use of information to identify hazards.
Estimation of risk associated with identified hazards.
Comparison of analyzed risk against given risk criteria.
Decision making to reduce and/or accept risks.
ADE (mg/day) = NOAEL (mg/kg/day) x BW (kg)
UFC x MF
NOAEL = No-observed-adverse-effect level
BW = Body weight
UFC = Composite uncertainty factor(s)
MF = Modifying factor
ADE = 1 µg/day
ADE = 10 µg/day
ADE = 100 µg/day
Provides guidance for unstudied compounds that fall into one of three categories:
Dolan DG, Naumann BD, Sargent EV, Maier A, Dourson M Application of the threshold of toxicological concern concept to pharmaceutical manufacturing operations. Regul. Tox. Pharm. 43:1-9 (2005)
(Parenteral Drug Association cleaning guidance, 1992)
Testing and release process inside ventilated enclosure