Review ArticlePQRI Special Section
The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
Diane Paskiet
1West Pharmaceutical Services, Exton PA, USA;
Dennis Jenke
2Baxter Healthcare Corporation, Round Lake, IL, USA;
Douglas Ball
3Pfizer, Inc., Groton, CT, USA;
Christopher Houston
4Bausch & Lomb, Rochester, NY, USA;
Daniel L. Norwood
5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; and
Ingrid Markovic
6United States Food and Drug Administration, Washington, DC, USA

References
- 1.↵
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Guidance for Industry—Container Closure Systems for Packaging Human Drugs and Biologics, 1999.
- 2.↵
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Draft Guidance for Industry—Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products, 1998.
- 3.↵
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry—Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Chemistry, Manufacturing, and Controls Documentation, 2002.
- 4.↵
European Medicines Agency, Committee for Medicinal Products for Human and Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP). Guideline on Plastic Immediate Packaging Materials, 2005.
- 5.↵
Product Quality Research Institute (PQRI), Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products; Product Quality Research Institute: Arlington, VA, 2006.
- 6.↵
- Ball D.,
- Paskiet D.,
- Norwood D. L.,
- Jenke D.
- 7.↵
PQRI. Parenteral and Ophthalmic Drug Products (PODP) Work Plan; Product Quality Research Institute: Arlington, VA, 2008; available at http://www.pqri.org/commworking/minutes/pdfs/dptc/podpwg/Addl/podp_work_plan_schedule.pdf.
- 8.↵
Study Protocol—Stage 1 Experimental Protocol for Qualitative Controlled Extraction Studies for Material Test Articles Representative of Prefilled Syringe (PFS) and Small Volume Parenteral (SVP) Container Closure Systems, Amendment #1; Product Quality Research Institute: Arlington, VA, September 2011; available at http://www.pqri.org/commworking/minutes/pdfs/dptc/podpwg/Addl/StudyProtocolStage1amend1.pdf.
- 9.↵
U.S. Department of Health and Human Services, Food and Drug Administration, Pharmaceutical Quality for the 21st Century A Risk-based Approach. 2009; available at http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm071836.
- 10.↵
- Jenke D.
- 11.↵
- Jenke D.
- 12.↵
- Jenke D.
- 13.
- Jenke D.
- 14.↵
International Atomic Energy Agency. Controlling Degradation Effects in Radiation of Processing Polymers, IAEA-TECDOC 1611, Vienna, Austria, 2009, ISSN 1011–4289.
- 15.↵
- 16.↵
- 17.↵
- 18.↵
- Jaehnke R. W. O.,
- Joerg R. G.
- 19.↵
- Jaehnke R. W. O.,
- Linde H.,
- Mosandl A.,
- Kreuter J.
- 20.↵
- Danielson J. W.
- 21.↵
- 22.↵
- Sharma B.,
- Bader F.,
- Templeman T.,
- Lisi P.,
- Ryan M.,
- Heavner G. A.
- 23.↵
- Pang J.,
- Blanc T.,
- Brown J.,
- Labrenz S.,
- Villalobos A.,
- Depaolis A.,
- Gunturi S.,
- Grossman S.,
- Lisi P.,
- Heavner G. A.
- 24.↵
- Driver W. E.
- 25.↵
- 26.↵
- Arbin A.,
- Ostelius J.,
- Callmer K.,
- Sroka J.,
- Hanninen K.,
- Axelsson A.
- 27.↵
- Srivastava S. P.,
- Saxena A. K.,
- Seth P. K.
- 28.↵
- Snell R. P.
- 29.↵
- 30.↵
- 31.↵
- 32.↵
- Hill S. S.,
- Shaw B. R.,
- Wu A. H. B.
- 33.↵
- Nakamura Y.,
- Nakazawa K.,
- Ohmori S.,
- Kawano K.,
- Shin'ichirou N.,
- Kitada M.
- 34.↵
The National Toxicology Annual Report, 2011, The Phthalate Initiative, NIH 12-5971, http://ntp.niehs.nih.gov/ntp/Pubs/NTP2011_AnnualReport_508.pdf#search=dehp.
- 35.↵
- Seymour R. B.,
- Cheng T.
- 36.↵
- Nollet L. M. L.
- 37.↵
- Jenke D. R.,
- Zietlow D.,
- Garber M. J.,
- Sadain S.,
- Reiber D.,
- Terbush W.
- 38.↵
- 39.↵
- 40.↵
- Jakobs A.
- 41.↵
- Grimm M.
- 42.↵
U.S. Food and Drug Administration. Response to Petition on Bisphenol A (BPA). Available at http://www.fda.gov/Food/FoodborneIllnessContaminants/ChemicalContaminants/ucm166145.htm
- 43.↵
- Haishima Y.,
- Hayashi Y.,
- Yagami T.,
- Nakamura A.
- 44.↵
- 45.↵
Study Phase 2 Experimental Protocol for Simulation Study of Blow-Fill-Seal (PFS), PODP Container Closure Systems, September 2011, http://www.pqri.org/commworking/minutes/pdfs/dptc/podpwg/Addl/StudyProtocolStage2.pdf.
- 46.↵
Product Quality Research Institute (PQRI) PODP Working Group. PQRI Workshop on Safety Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products; and Poster Exhibit, Bethesda, MD, February 22–23, 2011; http://www.pqri.org/workshops/PODP11/pdfs/Agenda_final_program.pdf.
- 47.↵
- Munro I. C.,
- Ford R. A.,
- Kennepohl E.,
- Sprenger J. G.,
- Maier A.,
- Dourson M.
- 48.↵
- Kroes R.,
- Renwick A.,
- Cheeseman M.,
- Kleiner J.,
- Mangelsdorf I.,
- Piersma A.,
- Schilter B.,
- Schlatter J.,
- van Schothorst F.,
- Vos J.,
- Würtzen G.
- 49.↵
ToxTree. Toxic Hazard Estimation by Decision Tree Approach; http://ihcp.jrc.ec.europa.eu/our_labs/predictive_toxicology/qsar_tools/toxtre.
- 50.↵
- Cramer G. M.,
- Ford R. A.,
- Hall R. L.
- 51.↵
Deductive Estimation of Risk from Existing Knowledge (DEREK); https://www.lhasalimited.org/derek_nexus
- 52.↵
- Ball D. J.
- 53.↵
- Ng L.
- 54.↵
International Conference on Harmonization (ICH) M7; Assessment and Control of DNA (Mutagenic) Reactive Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, February 2013; http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_2.pdf.
- 55.↵
- Markovic I.
- 56.↵
- Markovic I.
- 57.↵
- Markovic I.
- 58.↵
- 59.↵
- Yano K.,
- Ohno S.,
- Nakajima Y.,
- Toyoshima S.,
- Nakajin S.
- 60.↵
- Beck-Speier I.,
- Kreyling W. G.,
- Maier K. L.,
- Dayal N.,
- Schladweiler M. C.,
- Mayer P.,
- Semmler-Behnke M.,
- Kodavanti U. P.
- 61.↵
- Lovik M.,
- Hogseth A. K.,
- Gaarder P. I.,
- Hagemann R,
- Eide I.
- 62.↵
- Nilsen A.,
- Hagemann R.,
- Eide I.
- 63.↵
- Larsen S. T.,
- Lund R. M.,
- Nielsen G. D.,
- Thygesen P.,
- Poulsen O. M.
- 64.↵
- Larsen S. T.,
- Hansen J. S.,
- Thygesen P,
- Begtrup M.,
- Poulsen O. M.,
- et al
- 65.↵
- 66.↵
- Locatelli F.,
- Aljama P.,
- Barany P.,
- et al
- 67.↵
- 68.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 5
September/October 2013
The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 430-447; DOI: 10.5731/pdajpst.2013.00936
The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 430-447; DOI: 10.5731/pdajpst.2013.00936
Jump to section
Related Articles
- No related articles found.
Cited By...
- Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
- Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
- Integration of Regulatory Guidelines into Protein Drug Product Development
- Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products