title: Best practices for extractables and leachables in orally inhaled and nasal drug products: an overview of the PQRI recommendations.
abstract: The Product Quality Research Institute Leachables and Extractables Working Group includes pharmaceutical development scientists representing industry, government, and academia. The Working Group was created and constituted to address scientific and regulatory questions concerning the pharmaceutical development process for Orally Inhaled and Nasal Drug Products (OINDP) related to organic extractables and leachables. This effort has resulted in the creation of a detailed "Recommendation Document", which was submitted to the U.S. FDA for consideration in September 2006. The recommendations include proposed safety and analytical thresholds for leachables and extractables, as well as detailed "best practice" recommendations for various aspects of the OINDP pharmaceutical development process, including: materials selection for OINDP container closure system components, Controlled Extraction Studies, Leachables Studies, and Routine Extractables Testing. The Working Group's processes and the detailed and comprehensive recommendations that resulted from those processes, demonstrate that the Product Quality Research Institute collaborative process can result in consensus science-based and data driven recommendations that could have a positive effect on patient care. It is anticipated that the Working Group's recommendations will also contribute to the new "Quality by Design" pharmaceutical development paradigm. This commentary summarizes the best practice recommendations within the context of an overall pharmaceutical development process.
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Norwood
authors.forename: Diane
authors.initials: D
authors.lastname: Paskiet
authors.forename: Michael
authors.initials: M
authors.lastname: Ruberto
authors.forename: Thomas
authors.initials: T
authors.lastname: Feinberg
authors.forename: Alan
authors.initials: A
authors.lastname: Schroeder
authors.forename: Guirag
authors.initials: G
authors.lastname: Poochikian
authors.forename: Qingxi
authors.initials: Q
authors.lastname: Wang
authors.forename: Tian Jing
authors.initials: TJ
authors.lastname: Deng
authors.forename: Fran
authors.initials: F
authors.lastname: DeGrazio
authors.forename: Melinda K
authors.initials: MK
authors.lastname: Munos
authors.forename: Lee M
authors.initials: LM
authors.lastname: Nagao
mesh_terms: D000280:Administration, Inhalation; D000281:Administration, Intranasal; D000284:Administration, Oral; D019985:Benchmarking; D003257:Consumer Product Safety; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging; D008401:Gas Chromatography-Mass Spectrometry / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000592:standards*; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations