Assessment of Extractable and Leachable Substances from Pharmaceutical Contact Materials: Where Are We and Where Do We Go from Here?

References

1. 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. 2.↵
   U.S. Pharmacopeial Convention, General Chapter <661> Plastic Packaging Systems and Their Materials of Construction. To be official November 1, 2020.
3. 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. 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. 5.↵
   U.S. Pharmacopeial Convention, General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. To be official December 1, 2020.
6. 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. 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. 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. 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. 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. 11.↵
    International Conference for Harmonisation, Quality Guideline Q3E: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics. Currently being drafted.