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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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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 Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
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Keywords

  • quality risk management
  • Microbiological Contamination
  • Warning letters
  • Non-Sterile Drug Products

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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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