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PDA Journal of Pharmaceutical Science and Technology

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A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016

Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes
PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
Ana M. C. Santos
1Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003 Lisbon, Portugal;
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Mara S. Doria
1Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003 Lisbon, Portugal;
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Luís Meirinhos-Soares
3INFARMED Autoridade Nacional do Medicamento, Av. do Brasil 53, 1749-004 Lisbon, Portugal
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António J. Almeida
1Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003 Lisbon, Portugal;
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José C. Menezes
2Institute for Biotechnology and Biosciences – Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1 – 1049-001 Lisbon, Portugal; and
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  • For correspondence: bsel@Tecnico.ULisboa.pt
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Article Information

vol. 72 no. 1 62-72
DOI 
https://doi.org/10.5731/pdajpst.2016.007252
PubMed 
29242394

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online January 30, 2018.

Article Versions

  • previous version (December 14, 2017 - 17:10).
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Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Ana M. C. Santos1,
  2. Mara S. Doria1,
  3. Luís Meirinhos-Soares3,
  4. António J. Almeida1 and
  5. José C. Menezes2,*
  1. 1Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003 Lisbon, Portugal;
  2. 2Institute for Biotechnology and Biosciences – Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1 – 1049-001 Lisbon, Portugal; and
  3. 3INFARMED Autoridade Nacional do Medicamento, Av. do Brasil 53, 1749-004 Lisbon, Portugal
  1. ↵*Corresponding Author: Institute for Biotechnology and Biosciences—Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais 1, 1049-001 Lisbon, Portugal; e-mail: bsel{at}Tecnico.ULisboa.pt
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PDA Journal of Pharmaceutical Science and Technology: 72 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
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A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida, José C. Menezes
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 62-72; DOI: 10.5731/pdajpst.2016.007252

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A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida, José C. Menezes
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 62-72; DOI: 10.5731/pdajpst.2016.007252
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Keywords

  • Quality risk management
  • Microbiological Contamination
  • Warning Letters
  • Non-Sterile Drug Products

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