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A proof-of-concept study on a universal standard kit to evaluate the risks of inspectors for their foundational ability of visual inspection of injectable drug products

Hirohito Katayama, Manabu Tsuda, Yukari Koga, Nobuaki Habasaki, Kosuke Taniyama, Yuichi Minato, Akihiro Oda, Kouichi Nagata, Takashi Amagasa and Kimitaka Misawa
PDA Journal of Pharmaceutical Science and Technology March 2025, pdajpst.2023.012911; DOI: https://doi.org/10.5731/pdajpst.2023.012911
Hirohito Katayama
1 CM Plus Corporation;
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  • For correspondence: katayama@cm-plus.co.jp
Manabu Tsuda
2 Mitsubishi Tanabe Pharma Corporation;
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  • For correspondence: tsuda.manabu@md.mt-pharma.co.jp
Yukari Koga
3 Kyowa Kirin Co. Ltd.;
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  • For correspondence: yukari.koga.p1@kyowakirin.com
Nobuaki Habasaki
4 Idorsia Pharmaceuticals Ltd;
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  • For correspondence: nhabasaki@gmail.com
Kosuke Taniyama
5 Cytiva;
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  • For correspondence: kosuke_taniyama@ap.pall.com
Yuichi Minato
3 Kyowa Kirin Co. Ltd.;
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  • For correspondence: yuichi.minato.qj@kyowakirin.com
Akihiro Oda
6 Namicos Corporation;
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  • For correspondence: akihiro-oda@namicos.co.jp
Kouichi Nagata
6 Namicos Corporation;
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  • For correspondence: kouichi-nagata@namicos.co.jp
Takashi Amagasa
7 Terumo Co. Ltd;
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  • For correspondence: takashi_amagasa@terumo.co.jp
Kimitaka Misawa
8 Shionogi Pharma Co. Ltd.
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  • For correspondence: kimitaka.misawa@shionogi.co.jp
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Article Information

pdajpst.2023.012911
DOI 
https://doi.org/10.5731/pdajpst.2023.012911
PubMed 
40132885

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received October 15, 2023
  • Accepted March 5, 2025
  • Published online March 25, 2025.

Article Versions

  • You are currently viewing a previous version of this article (March 25, 2025 - 11:38).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2025, Parenteral Drug Association

Author Information

  1. Hirohito Katayama1,9 (katayama{at}cm-plus.co.jp),
  2. Manabu Tsuda2 (tsuda.manabu{at}md.mt-pharma.co.jp),
  3. Yukari Koga3 (yukari.koga.p1{at}kyowakirin.com),
  4. Nobuaki Habasaki4 (nhabasaki{at}gmail.com),
  5. Kosuke Taniyama5 (kosuke_taniyama{at}ap.pall.com),
  6. Yuichi Minato3 (yuichi.minato.qj{at}kyowakirin.com),
  7. Akihiro Oda6 (akihiro-oda{at}namicos.co.jp),
  8. Kouichi Nagata6 (kouichi-nagata{at}namicos.co.jp),
  9. Takashi Amagasa7 (takashi_amagasa{at}terumo.co.jp) and
  10. Kimitaka Misawa8 (kimitaka.misawa{at}shionogi.co.jp)
  1. 1 CM Plus Corporation;
  2. 2 Mitsubishi Tanabe Pharma Corporation;
  3. 3 Kyowa Kirin Co. Ltd.;
  4. 4 Idorsia Pharmaceuticals Ltd;
  5. 5 Cytiva;
  6. 6 Namicos Corporation;
  7. 7 Terumo Co. Ltd;
  8. 8 Shionogi Pharma Co. Ltd.
  1. ↵* Corresponding author; email: katayama{at}cm-plus.co.jp

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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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A proof-of-concept study on a universal standard kit to evaluate the risks of inspectors for their foundational ability of visual inspection of injectable drug products
Hirohito Katayama, Manabu Tsuda, Yukari Koga, Nobuaki Habasaki, Kosuke Taniyama, Yuichi Minato, Akihiro Oda, Kouichi Nagata, Takashi Amagasa, Kimitaka Misawa
PDA Journal of Pharmaceutical Science and Technology Mar 2025, pdajpst.2023.012911; DOI: 10.5731/pdajpst.2023.012911

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A proof-of-concept study on a universal standard kit to evaluate the risks of inspectors for their foundational ability of visual inspection of injectable drug products
Hirohito Katayama, Manabu Tsuda, Yukari Koga, Nobuaki Habasaki, Kosuke Taniyama, Yuichi Minato, Akihiro Oda, Kouichi Nagata, Takashi Amagasa, Kimitaka Misawa
PDA Journal of Pharmaceutical Science and Technology Mar 2025, pdajpst.2023.012911; DOI: 10.5731/pdajpst.2023.012911
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Keywords

  • comparability
  • foreign matter
  • foundational ability
  • human inspector
  • universal standard
  • Visual inspection

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