Review ArticleReview
Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005
Dennis R. Jenke
1Baxter Healthcare Corporation, Round Lake, IL;
Cheryl L. M. Stults
2Novartis Pharmaceuticals Corporation, San Carlos, CA;
Diane M. Paskiet
3West Pharmaceutical Services, Exton, PA;
Douglas J. Ball
4Pfizer, Inc., Groton, CT; and
Lee M. Nagao
5Drinker Biddle and Reath, LLP, Washington, DC
References
- 1.↵
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline. Impurities in New Drug Products. Q3B(R2). Current Step 4 Version, June 2, 2006.
- 2.↵
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Draft Consensus Guideline. Guideline for Elemental Impurities. Q3D. Current Step 2b Version, July 26, 2013.
- 3.↵
<232> Elemental Imputrities—Limits. In The United States Pharmacopeia, USP 35–NF30, Supplement No. 2; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2012; pp 5633, 5634.
- 4.↵
ICH. ICH Harmonised Tripartite Guideline. Pharmaceutical Development. Q8(R2). Current Step 4 Version, August, 2009.
- 5.↵
ICH. ICH Harmonised Tripartite Guideline. Quality Risk Management. Q9. Current Step 4 Version, November 9, 2005.
- 6.↵
ICH. ICH Harmonised Tripartite Guideline. Pharmaceutical Development. Q10. Current Step 4 Version, June 4, 2008.
- 7.↵
- Markovic I.
- 8.↵
- Nashed-Samuel Y.,
- Liu D.,
- Fujimori K.,
- Preez L.,
- Lee H.
- 9.↵
- 10.↵
- Liu W.,
- Swift R.,
- Torraca G.,
- Nashed-Samuel Y.,
- Wen Z.,
- Vance A.,
- Mire-Sluis A.,
- Freund. E.,
- Davis J.,
- Narhi L.
- 11.↵
- Castner J.,
- Williams N.,
- Bresnick M.
- 12.↵
- Jenke D.,
- Rivera C.,
- Mortensen T.,
- Amin P.,
- Chacko M.,
- Tran T.,
- Chum J.
- 13.↵
- Jenke D. R.
- 14.↵
- Jenke D. R.
- 15.↵
- Milano E. A.,
- Waraszkiewicz M.,
- Dirubio R.
- 16.↵
- Alam M. S.,
- Srivastava S. P.,
- Seth P. K.
- 17.↵
- Desai N. R.,
- Shah S. M.,
- Koczone J.,
- Vencl-Joncic M.,
- Sisto C.,
- Ludwig S. A.
- 18.↵
- Ding W.,
- Nash R.
- 19.↵
- Allain L.,
- Wang Q.
- 20.↵
- Lamberty A.,
- Van Borm W.,
- Quevauviller P.
- 21.↵
- Fordham P. J.,
- Gramshaw J. W.,
- Crews H. M.,
- Castle L.
- 22.↵
- Pluhator-Murton M.M.,
- Fedorak R.N.,
- Audette R.J.,
- Marriage B.J.,
- Yatscoff R. W.,
- Gramlich L. M.
- 23.↵
- Fliszar K. A.,
- Walker D.,
- Allain L.
- 24.↵
- Zuccarello D. J.,
- Murphy M. P.,
- Meyer R. F.,
- Winslow P. A.
- 25.↵
- 26.↵
- 27.↵
- Longas N.,
- Arrona R. G.,
- Ostra M.,
- Millian E.
- 28.↵
- Waheed S.,
- Rahman S.,
- Husnain S. M.,
- Siddique N.
- 29.↵
- Nita S.,
- Rughinis R.,
- Rusa N.,
- Balas R.
- 30.↵
- Shotyk W.,
- Krachler M.,
- Chen B.
- 31.↵
- Perring L.,
- Alonso M.,
- Andrey D.,
- Bourqui R.,
- Zbinden P.
- 32.↵
- Flores E. M. M.,
- Muller E. I.,
- Duarte F. A.,
- Grinberg P.,
- Sturgeon R. E.
- 33.↵
- Skrzydlewska E.,
- Balcerzak M.,
- Vanhaecke F.
- 34.↵
- Padovese P.,
- Gallieni M.,
- Brancaccio D.,
- Pietra R.,
- Fortaner S.,
- Sabbioni E.,
- Minoia C.,
- Markakis K.,
- Berlin A.
- 35.↵
- Jenke D.,
- Castner J.,
- Egert T.,
- Feinberg T.,
- Hendricker A.,
- Houston C.,
- Hunt D. G.,
- Lynch M.,
- Shaw A.,
- Nicholas K.,
- Norwood D. L.,
- Paskiet D.,
- Ruberto M.,
- Smith E. J.,
- Holcomb F.
- 36.↵
- Ding W.
- 37.↵
- Guadagnino E.,
- Zuccato D.
- 38.↵
- Ledieu A.,
- Devreux F.,
- Barboux P.,
- Sicard L.,
- Spalla O.
- 39.↵
- 40.↵
- Jenke D.,
- Odufu A.,
- Couch T.,
- Chacko M.,
- Strathmann S.,
- Edgcomb E.
- 41.↵
- Nedich R. L.
- 42.↵
- Mondimore D.,
- Moore C.
- 43.↵
- Fordham P. J.,
- Gramshaw J. W.,
- Castle L.,
- Crews H. M.,
- Thompson D.,
- Parry S. J.,
- McCurdy E.
- 44.↵
- Thompson D.,
- Parry S. J.,
- Benzing R.
- 45.↵
- Bohrer D.,
- do Nascimento P. C.,
- Binotto R.,
- Becker E.
- 46.↵
- Pavanetto F.,
- Genta I.,
- Conti B.,
- Modena T,
- Montanari L.
- 47.↵
- 48.↵
- Skrzydlewska E.,
- Balcerzak M.
- 49.↵
- Thompson D.,
- Perry S. J.,
- Benzing R.
- 50.↵
- Hayes P.,
- Martin T. P.,
- Pybus J.
- 51.↵
- 52.↵
- Quagliaro D. A.,
- Geraci V. A.,
- Dwan R. E.
- 53.↵
- 54.↵
- Jenke D. R.,
- Story J.,
- Lalani R.
- 55.↵
- Zhou S.,
- Lewis L. M.,
- Singh S. K.
- 56.↵
- Teasdale A.,
- Jahn M.,
- Bailey S.,
- Feilden A.,
- Taylor G.,
- Corcoran M.,
- Malick R.,
- Jenke D.,
- Nagao L.
- 57.↵
- Baidoo I. K.,
- Nyarko B. J. B.,
- Akaho E. H. K.,
- Dampare S. B.,
- Poku L. O.,
- Gbadgo J. K.,
- Quacoo E. A.,
- Opata N. S.,
- Quagraine R. E.
- 58.↵
- Sakurai H.,
- Nono J.,
- Kawase A.,
- Fujinami M.,
- Oguma K.
- 59.↵
- Malaxechevarria Y.,
- Millan E.
- 60.↵
- Lee K. Y.,
- Shim S. K.,
- Yoon Y. Y.,
- Chung Y. S,
- Lee G. H.
- 61.↵
- Nissen K. E.,
- Keegan J. T.,
- Byrne J. P.
- 62.↵
European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on the Specification Limits for Residuals of Metal Catalysts or Metal Reagents. 1 September 2008.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball, Lee M. Nagao
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 1-48; DOI: 10.5731/pdajpst.2015.01005
Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball, Lee M. Nagao
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 1-48; DOI: 10.5731/pdajpst.2015.01005
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