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A risk‐based approach to managing active pharmaceutical ingredients in manufacturing effluent
Author(s) -
Caldwell Daniel J.,
Mertens Birgit,
Kappler Kelly,
Senac Thomas,
Journel Romain,
Wilson Peter,
Meyerhoff Roger D.,
Parke Neil J.,
Mastrocco Frank,
Mattson Bengt,
MurraySmith Richard,
Dolan David G.,
Straub Jürg Oliver,
Wiedemann Michael,
Hartmann Andreas,
Finan Douglas S.
Publication year - 2016
Publication title -
environmental toxicology and chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.1
H-Index - 171
eISSN - 1552-8618
pISSN - 0730-7268
DOI - 10.1002/etc.3163
Subject(s) - risk analysis (engineering) , pharmaceutical industry , pharmaceutical manufacturing , effluent , good manufacturing practice , business , computer science , biochemical engineering , engineering , waste management , microbiology and biotechnology , supply chain , marketing , biology , bioinformatics
Abstract The present study describes guidance intended to assist pharmaceutical manufacturers in assessing, mitigating, and managing the potential environmental impacts of active pharmaceutical ingredients (APIs) in wastewater from manufacturing operations, including those from external suppliers. The tools are not a substitute for compliance with local regulatory requirements but rather are intended to help manufacturers achieve the general standard of “no discharge of APIs in toxic amounts.” The approaches detailed in the present study identify practices for assessing potential environmental risks from APIs in manufacturing effluent and outline measures that can be used to reduce the risk, including selective application of available treatment technologies. These measures either are commonly employed within the industry or have been implemented to a more limited extent based on local circumstances. Much of the material is based on company experience and case studies discussed at an industry workshop held on this topic. Environ Toxicol Chem 2016;35:813–822. © 2015 The Authors. Environmental Toxicology and Chemistry Published by Wiley Periodicals, Inc. on behalf of SETAC.