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

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 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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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

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Published online January 30, 2018.

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previous version (December 14, 2017 - 17:10).
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Ana M. C. Santos1,
Mara S. Doria1,
Luís Meirinhos-Soares3,
António J. Almeida1 and
José C. Menezes2,*

¹Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Professor Gama Pinto, 1649-003 Lisbon, Portugal;
²Institute for Biotechnology and Biosciences – Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1 – 1049-001 Lisbon, Portugal; and
³INFARMED Autoridade Nacional do Medicamento, Av. do Brasil 53, 1749-004 Lisbon, Portugal

↵*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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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
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Non-Sterile Drug Products

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