Article CommentaryCommentary
A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 506-535; DOI: https://doi.org/10.5731/pdajpst.2020.012617
Dennis Jenke
Triad Scientific Solutions, LLC, Hawthorn Wood, IL 60047 USA

References
- 1.↵Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Documentation; U.S. Department of Health and Human Services, Food and Drug Administration; Rockville, MD, 1999.
- 2.↵U.S. Pharmacopeial Convention, General Chapter <1664> Assessment of Leachables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 41-NF 36, USP: Rockville, MD, 2018.
- 3.↵
- Jenke D.
- 4.↵BioPhorum Operations Group. Biophorum Operations Group (BPOG) Best Practices Guide for Evaluating Leachables Risk from Polymeric Single-Use Systems Used in Biopharmaceutical Manufacturing, 2018. https://www.biophorum.com/wp-content/uploads/bp_downloads/Leachables-report-12-April-2017-v3-1.pdf (accessed December 5, 2021).
- 5.↵
- Jenke D.
- 6.↵U.S. Pharmacopeial Convention, General Chapter <1665> Characterization of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. In PF46(5), USP: Rockville, MD, 2020.
- 7.↵Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry: M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; U.S. Department of Health and Human Services, Food and Drug Administration; Rockville, MD, 2018.
- 8.↵Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP). Guideline on Plastic Immediate Packaging Materials. CPMP/QWP/4359/03; European Medicines Agency Inspections; London, UK, 2005.
- 9.↵U.S. Pharmacopeial Convention, General Chapter <661.1> Plastic Materials of Construction. In USP43–NF38: Document ID, GUID-560BA7C5-176D-4976-8AB2-A051582B39C7_10_en-US, USP: Rockville, MD, not yet official.
- 10.↵U.S. Pharmacopeial Convention, General Chapter <87> Biological Reactivity Tests, In Vitro. In USP43–NF38, USP: Rockville, MD, 2016, 6514.
- 11.↵U.S. Pharmacopeial Convention, General Chapter <88> Biological Reactivity Tests, In Vivo. In USP43–NF38, USP: Rockville, MD, 2013, 6516.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 6
November/December 2021
A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 506-535; DOI: 10.5731/pdajpst.2020.012617
Jump to section
- Article
- Abstract
- Introduction
- The FDA 1999 Container Closure Guidance as an Example of Risk-Based Testing Requirements
- Risk Classification of Packaging Systems
- Example Classifications
- Assessments of Drug Products, Packaging Systems, and Materials of Construction Based on Risk Classification
- Conclusion
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.
Cited By...
- No citing articles found.