Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3—Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices

References

1. 1.↵
   U.S. Food and Drug Administration. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, 1999.
2. 2.↵
   European Medicines Agency. Guideline on Plastic Immediate Packaging Materials. EMA: London, 2005.
3. 3.↵
   1. Jenke D.

   Material Screening and Characterization. In Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables; John Wiley and Sons: Hoboken, NY, 2009; Chapter 4, pp 124–131.
4. 4.↵
   1. Ball D. J.,
   2. Norwood D. L.,
   3. Stults C. L. M.,
   4. Nagao L. M.

   1. Norwood D. L.,
   2. Feinberg T. N.,
   3. Mullis J. O.,
   4. Pennino C. J.

   Analytical Techniques for Identification and Quantitation of Extractables and Leachables. In Leachables and Extractables Handbook: Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products; Ball D. J., Norwood D. L., Stults C. L. M., Nagao L. M., Eds.; John Wiley and Sons: Hoboken, NY, 2012; Chapter 13, pp 241–288.
5. 5.↵
   U.S. Pharmacopeial Convention. General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 41–NF 36; USP: Rockville, MD, 2018; p 7910.
6. 6.↵
   1. Christiaens P.,
   2. Beusen J. M.,
   3. Verlinde P.,
   4. Baeten J.,
   5. Jenke D.

   Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1: Introduction to Errors in Chromatographic Screening for Organic Extractables & Leachables and Discussion of the Error of Omission. PDA J. Pharm. Sci. Technol. 2020, 74 (1), 90–107.

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. Christiaens P.,
   2. Beusen J. M.,
   3. Verlinde P.,
   4. Baeten J.,
   5. Jenke D.

   Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2: the Errors of Inexact Identification and Inaccurate Quantitation. PDA J. Pharm. Sci. Technol. 2020, 74 (1), 108–130.

   OpenUrlAbstract/FREE Full Text
8. 8.↵
   1. Swartz M. E.,
   2. Krull I. S.

   Analytical Method Development and Validation; Marcel Dekker: New York, 1997.
9. 9.↵
   1. Jenke D.

   The Early Development Stage; Method Development, Evaluation and Validation. In Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables; John Wiley and Sons: Hoboken, NY, 2009; Chapter 6, p 205.
10. 10.↵
    1. Ball D. J.,
    2. Norwood D. L.,
    3. Stults C. L. M.,
    4. Nagao L. M.

    1. Norwood D. L.,
    2. Feinberg T. N.,
    3. Mullis J. O.,
    4. Pennino C. J.

    Analytical Leachables Studies. In Leachables and Extractables Handbook: Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products; Ball D. J., Norwood D. L., Stults C. L. M., Nagao L. M., Eds.; John Wiley and Sons: Hoboken, NY, 2012; Chapter 17, p 438.
11. 11.↵
    U.S. Pharmacopeial Convention. General Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 41–NF 36; USP: Rockville, MD, 2018, p 7916.