Best Practices for OINDP Pharmaceutical Development Programs Leachables and Extractables
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1 Best Practices for OINDP Pharmaceutical Development Programs Leachables and Extractables PQRI Leachables & Extractables Working Group PQRI Training Course April 2007 Chicago, IL
2 What are leachables and extractables? Extractables Compounds that can be extracted from elastomeric, plastic components or coatings of the container and closure system when in the presence of an appropriate solvent(s). Abundance TIC: D Time--> Leachables Compounds that leach from elastomeric, plastic components or coatings of the container and closure system as a result of direct contact with the formulation. Abundance TIC: D April 2007 PQRI Training Course Time-->
3 What are OINDP? Metered Dose Inhalers Dry Powder Inhalers Inhalation Solutions Inhalation Sprays Nasal Sprays MDI Schematic Provided by Bespak Europe April 2007 PQRI Training Course 3
4 Why are we interested leachables FDA Guidances: Approvals: and extractables? Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation; Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing, and Controls Documentation We want them!!!!!!! Ethical and professional obligations. April 2007 PQRI Training Course 4
5 We want approvals!!!!!!!!!!!!!! April 2007 PQRI Training Course 5
6 I ve heard it all!!!!!!!!!! A A person is exposed to more PNAs standing behind a city bus than from an MDI. One charbroiled steak is equal to 1,000,000 MDIs! Bloody Americans over the top as usual!!!!!! We have horror-stories. April 2007 PQRI Training Course 6
7 What is PQRI? Product Quality Research Institute Not-for for-profit, non-stock, tax-exempt entity incorporated in Virginia Serves as a forum for academia, industry and FDA to work cooperatively Working Group on Leachables and Extractables currently in operation April 2007 PQRI Training Course 7
8 PQRI Member Organizations AAPS Consumer Healthcare Products Association PDA PhRMA U.S. FDA, Center for Drug Evaluation and Research BIO International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) International Pharmaceutical Excipients Council of the Americas (IPEC) USP April 2007 PQRI Training Course 8
9 The International Pharmaceutical Aerosol Consortium (IPAC) formed in 1989 to address regulatory consequences for MDIs of Montreal and Kyoto Protocols In 2001, the International Pharmaceutical Aerosol Consortium for Regulation and Science (IPAC-RS) was officially formed as a separate Consortium IPAC-RS Mission: To advance consensus- based and scientifically driven standards and regulations for inhaled and nasal drug products (OINDP). IPAC-RS Overall Goal: Development of scientifically justified regulatory approaches for orally inhaled and nasal drug products April 2007 PQRI Training Course 9
10 History of PQRI Leachables and Extractables Working Group Proposal to develop thresholds and examine best practices for L&E in OINDP drafted by IPAC-RS and submitted to PQRI Working Group formed in 2001, consisting of chemists and toxicologists from FDA, industry and academia Working Group developed a hypothesis and step-wise plan to investigate per established PQRI process Workplan approved by PQRI DPTC and Steering Committee in 2002 Toxicologists and chemists formed sub-groups April 2007 PQRI Training Course 10
11 History of PQRI Leachables and Extractables Working Group Toxicologists: acquired data through extensive literature and database searches and analyses Chemists: acquired data by conducting extractions studies and placebo leachables study Developed recommendations, Safety Thresholds and Best Practices for Leachables and Extractables Testing in Orally Inhaled and Nasal Drug Products Submitted final to PQRI and FDA in summer 2006 Science and data-based recommendations to PQRI and FDA. Not a policy/regulatory document April 2007 PQRI Training Course 11
12 Leachables and Extractables Working Group Members Dan Norwood, Chair (IPAC-RS) Doug Ball (IPAC-RS) Jim Blanchard (IPAC-RS) Lidiette Celado (AAPS) Fran DeGrazio (PDA) T.J. Deng (Lab - PPD) Bill Doub (Lab - FDA) Tom Feinberg (AAPS) Alan Hendricker (Lab - Cardinal) Jeff Hrkach (AAPS) Roger McClellan (UNM) Tim McGovern (FDA) Diane Paskiet (PDA) Paul Curry (USP) Michael Ruberto (Lab - CIBA) Alan Schroeder (FDA) Mark Vogel (PhRMA( PhRMA) Charles Wang (PhRMA( PhRMA) Ron Wolff (IPAC-RS) Michael Golden (DPTC, IPAC-RS) Guirag Poochikian (DPTC, FDA) Gordon Hansen (SC, IPAC-RS) April 2007 PQRI Training Course 12
13 Recommendation Document Overview Introduction and Summary of Recommendations Derivation and justification of safety thresholds, and application of safety thresholds Chemistry Best Practices Appendices April 2007 PQRI Training Course 13
14 Best Practices Overview Application of safety thresholds Safety Concern Threshold (SCT) Qualification Threshold (QT) Integration of safety expertise into component selection, controlled extraction studies, leachables studies and routine extractables testing Analytical/chemistry Selection of components Controlled Extraction Studies Leachables Studies and Routine Extractables Testing The Analytical Evaluation Threshold (AET) April 2007 PQRI Training Course 14
15 Select components and/or raw materials Conduct risk assessment on information from supplier YES Pharmaceutical Development Process for OINDP Individual ingredient poses unacceptable risk? NO Conduct controlled extraction studies on components Individual extractable greater than or equal to the AET/SCT? Develop and validate extraction methods for routine quality control NO No further safety assessment NO Conduct leachables studies on drug product and placebo Individual leachable greater than or equal to the AET/SCT? Establish correlation between leachables and extractables profiles YES YES Report leachable to toxicologist for risk assessment Report extractable to toxicologist for risk assessment Establish acceptance criteria for leachables and extractables Go to safety qualification process April 2007 PQRI Training Course 15
16 Training Course Overview OINDP Container Closure Systems Safety Evaluation of Extractables and Leachables Analysis of Extractables and Leachables Characterization of Extractables Special Case Compounds Characterization of Leachables Quality Control and Specification Setting Panel Discussion April 2007 PQRI Training Course 16
17 Faculty Dan Norwood Director Physical and Chemical Analysis, Boehringer Ingelheim Pharmaceuticals, Inc. (Working Group Chair) Michael Ruberto Head Regulatory Services, Ciba Expert Services Doug Ball Research Fellow, Drug Safety, Pfizer, Inc. (Toxicology Subgroup Chair) Diane Paskiet Associate Director of Analytical Laboratories, West Monarch Analytical Labs James Mullis Senior Scientist, Physical and Chemical Analysis, Boehringer Ingelheim Pharmaceuticals, Inc. Tom Feinberg Director Structural Chemistry, Pharmaceutical Development, Cardinal Health Terry Tougas Highly Distinguished Scientist, Boehringer Ingelheim Pharmaceuticals, Inc. (DPTC Chair) April 2007 PQRI Training Course 17
18 Feedback April 2007 PQRI Training Course 18
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