OtherCase Studies
A QRM Discussion of Microbial Contamination of Non-Sterile Drug Products, using FDA's and EMA's Warning-Letters between 2008 and 2016.
Ana M.C. Santos, Mara S. Doria, Luis Soares, António J. Almeida and José C. Menezes
PDA Journal of Pharmaceutical Science and Technology December 2017, pdajpst.2016.007252; DOI: https://doi.org/10.5731/pdajpst.2016.007252
Ana M.C. Santos
1 Research Institute for Medicines, University of Lisbon;
Mara S. Doria
1 Research Institute for Medicines, University of Lisbon;
Luis Soares
2 INFARMED Autoridade Nacional do Medicamento;
António J. Almeida
1 Research Institute for Medicines, University of Lisbon;
José C. Menezes
3 Institute for Biotechnology and Biosciences, University of Lisbon
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 2
March/April 2024
A QRM Discussion of Microbial Contamination of Non-Sterile Drug Products, using FDA's and EMA's Warning-Letters between 2008 and 2016.
Ana M.C. Santos, Mara S. Doria, Luis Soares, António J. Almeida, José C. Menezes
PDA Journal of Pharmaceutical Science and Technology Dec 2017, pdajpst.2016.007252; DOI: 10.5731/pdajpst.2016.007252
A QRM Discussion of Microbial Contamination of Non-Sterile Drug Products, using FDA's and EMA's Warning-Letters between 2008 and 2016.
Ana M.C. Santos, Mara S. Doria, Luis Soares, António J. Almeida, José C. Menezes
PDA Journal of Pharmaceutical Science and Technology Dec 2017, pdajpst.2016.007252; DOI: 10.5731/pdajpst.2016.007252
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