title: A risk-based approach to managing active pharmaceutical ingredients in manufacturing effluent.
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.
authors.affiliation: Johnson & Johnson, New Brunswick, NJ, USA.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Caldwell
authors.affiliation: Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium.
authors.forename: Birgit
authors.initials: B
authors.lastname: Mertens
authors.affiliation: Johnson & Johnson Consumer Group of Companies, Skillman, New Jersey, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Kappler
authors.affiliation: Sanofi, Paris, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Senac
authors.affiliation: Sanofi, Paris, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Journel
authors.affiliation: Sanofi Bridgewater, New Jersey, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Wilson
authors.affiliation: Eli Lilly, Indianapolis, Indiana, USA.
authors.forename: Roger D
authors.initials: RD
authors.lastname: Meyerhoff
authors.affiliation: Eli Lilly, Indianapolis, Indiana, USA.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Parke
authors.affiliation: Pfizer, New York, New York, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Mastrocco
authors.affiliation: LIF, Swedish Association of the Pharmaceutical Industry, Stockholm, Sweden.
authors.forename: Bengt
authors.initials: B
authors.lastname: Mattson
authors.affiliation: AstraZeneca, Alderley Park, United Kingdom.
authors.forename: Richard
authors.initials: R
authors.lastname: Murray-Smith
authors.affiliation: Amgen, Thousand Oaks, California, USA.
authors.forename: David G
authors.initials: DG
authors.lastname: Dolan
authors.affiliation: F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Jürg Oliver
authors.initials: JO
authors.lastname: Straub
authors.affiliation: Bayer HealthCare, Leverkusen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Wiedemann
authors.affiliation: Novartis, Basel, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Hartmann
authors.affiliation: GSK, Research Triangle Park, North Carolina, USA.
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Finan
mesh_terms: D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D004785:Environmental Pollutants / Q000032:analysis* / Q000633:toxicity; D004364:Pharmaceutical Preparations / Q000032:analysis*; D018570:Risk Assessment; D062065:Wastewater / Q000032:analysis
chemical_list: D004785:Environmental Pollutants; D004364:Pharmaceutical Preparations; D062065:Wastewater
keywords: Active pharmaceutical ingredient; Maturity path; Wastewater effluent