Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System

References

1. 1.↵
   1. Colton R.

   ; BPSA Extractables and Leachables Subcommittee. Recommendations for extractables and leachables testing. Part 1: Introduction, regulatory issues, and risk assessment. BioProcess International 2007, 5(11), 36–44.

   OpenUrl
2. 2.↵
   Equipment Construction. Code of Federal Regulations, Foods and Drugs; Title 12, Part 211.65; U.S. Government Printing Office: Washington, DC. Revised April 1, 2011. www.accessdata.fda.gov/scripts/cdhr/cfdocs/cfcfr/CFRSearch.
3. 3.↵
   EUDRALEX Volume 4: Good Manufacturing Practices, Medical Products for Human and Veterinary Use. European Commission: Brussels, Belgium, 1998. http://ec.europa.eu/enterprise/pharaceuticals/eudralex/homev4.htm.
4. 4.↵
   Available at http://www.ich.org/LOB/media/MEDIA433.pdf.
5. 5.↵
   1. Colton R.,
   2. et al

   . Recommendations for extractables and leachables testing. Part 2: Executing a program. BioProcess International 2008, 6(1), 44–52.

   OpenUrl
6. 6.↵
   1. Tsui V.,
   2. Somma M. S.,
   3. Zitner L. A.

   Leachables evaluation for bulk drug substance. PDA J. Pharm. Sci. Technol. In press.
7. 7.↵
   1. Yu X.,
   2. Wood D.,
   3. Dong X.

   Extractables and leachables: study approach for disposable materials used in bioprocessing. BioProcess International 2008, 21(2), 42–51.

   OpenUrl
8. 8.↵
   1. Ding W.,
   2. Martin J.

   Implementing single-use technology in biopharmaceutical manufacturing: an approach to extractables/leachables studies. Part one: connectors and filters. BioProcess International 2008, 6(9), 34–42.

   OpenUrl
9. 9.↵
   1. Ding W.,
   2. Martin J.

   Implementing single-use technology in biopharmaceutical manufacturing: an approach to extractables/leachables studies. Part two: tubing and biocontainers. BioProcess International 2009, 7(5), 48–55.

   OpenUrl
10. 10.↵
    1. Bestwick D.,
    2. Colton R.

    Extractables and leachables from single-use disposables. BioProcess International 2009, 7(Suppl. 1), 88–94.

    OpenUrl
11. 11.↵
    1. Jenke D.

    Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachables; Wiley: Hoboken, NJ, 2009.
12. 12.↵
    Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, 1999.
13. 13.↵
    Guideline on Plastic Immediate Packaging Materials. European Medicines Agency, CPMP/QWWP/4359/03, EMEA/CVMP/205/04, 2005.
14. 14.↵
    Guidance for Industry. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products. Chemistry, Manufacturing, and Controls Documentation. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, 1998.
15. 15.↵
    Guidance for Industry. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products: Chemistry, Manufacturing, and Controls Documentation. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, 2002.
16. 16.↵
    Best Practices for OINDP Pharmaceutical Development Programs, Leachables and Extractables. Conference Proceedings of the Product Quality Research Institute (PQRI), Washington, DC, September 20–21, 2006. See also: Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. PQRI Leachables and Extractables Working Group, September 9, 2006. http://www.pqri.org/pdfs/LE-Recommendations-to-FDA-09-29-06.pdf.
17. 17.↵
    ANSI/AAMI BE83: 2006. Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Materials. Association for the Advancement of Medical Instrumentation (AAMI), American National Standards Institute (ANSI), 2006.
18. 18.↵
    Recommendations for Testing and Evaluation of Extractables from Single-Use Process Equipment. Bio-Process Systems Alliance: Washington, DC, 2010.
19. 19.↵
    1. Brennan J.,
    2. Bing F.,
    3. Boone H.,
    4. Fernandez J.,
    5. Miller D.,
    6. Seeley B.,
    7. Van Deinse H.

    Evaluation of extractables from product-contact surfaces. BioPharm International 2002, 15(12), 22–34.

    OpenUrl
20. 20.↵
    1. Green S.

    Assessing polymeric extractables and leachables for biopharamaceutical manufacturing. Am. Pharm. Rev. 2007, 10(6), 88–95.

    OpenUrl
21. 21.↵
    1. Wakankar A. A.,
    2. Wang Y. J.,
    3. Canova-Davis E.,
    4. Ma S.,
    5. Schmalzing D.,
    6. Grieco J.,
    7. Milby T.,
    8. Reynolds T.,
    9. Mazzarella K.,
    10. Hoff E.,
    11. Gomez S.,
    12. Martin-Moe S.

    On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals. J. Pharm. Sci. 2010, 99(5), 2209–2218.

    OpenUrlPubMed