EditorialGuest Editorial
Assessment of Extractable and Leachable Substances from Pharmaceutical Contact Materials: Where Are We and Where Do We Go from Here?
Steven A. Zdravkovic
PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 1-3; DOI: https://doi.org/10.5731/pdajpst.2021.012328
Steven A. Zdravkovic
PPD Laboratories, 8551 Research Way Suite 160, Middleton, WI 53562Telephone: 608-203-4364E-mail: Steve.zdravkovic@ppdi.com
References
- 1.↵Product Quality Research Institute Extractables and Leachables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drugs; PQRI, September 6, 2006.
- 2.↵U.S. Pharmacopeial Convention, General Chapter <661> Plastic Packaging Systems and Their Materials of Construction. To be official November 1, 2020.
- 3.↵U.S. Pharmacopeial Convention, General Chapter <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. Accessed current in process revision October 7, 2020.
- 4.↵U.S. Pharmacopeial Convention, General Chapter <1661> Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction. To be official November 1, 2020.
- 5.↵U.S. Pharmacopeial Convention, General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. To be official December 1, 2020.
- 6.↵U.S. Pharmacopeial Convention, General Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. To be official December 1, 2020.
- 7.↵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. Accessed current in process revision October 7, 2020.
- 8.↵International Organization for Standardization, ISO 10993-18:2020 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process. ISO: Geneva, 2020.
- 9.↵Recognized Consensus Standards: ISO 10993-18 Second Edition 2020-01. FR Recognition List Number 054. FR Recognition Number 2-276, 2020. U.S. Food and Drug Administration Web site. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=41050 (Accessed 31 August 2020).
- 10.↵International Organization for Standardization, ISO 10993-17:2002 Biological Evaluation of Medical Devices—Part 17: Establishment of Allowable Limits for Leachable Substances. ISO: Geneva, 2002.
- 11.↵International Conference for Harmonisation, Quality Guideline Q3E: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics. Currently being drafted.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 1
January/February 2021
Assessment of Extractable and Leachable Substances from Pharmaceutical Contact Materials: Where Are We and Where Do We Go from Here?
Steven A. Zdravkovic
PDA Journal of Pharmaceutical Science and Technology Jan 2021, 75 (1) 1-3; DOI: 10.5731/pdajpst.2021.012328
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