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

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 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

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.

Author Information

Hirohito Katayama1,9 (katayama{at}cm-plus.co.jp),
Manabu Tsuda2 (tsuda.manabu{at}md.mt-pharma.co.jp),
Yukari Koga3 (yukari.koga.p1{at}kyowakirin.com),
Nobuaki Habasaki4 (nhabasaki{at}gmail.com),
Kosuke Taniyama5 (kosuke_taniyama{at}ap.pall.com),
Yuichi Minato3 (yuichi.minato.qj{at}kyowakirin.com),
Akihiro Oda6 (akihiro-oda{at}namicos.co.jp),
Kouichi Nagata6 (kouichi-nagata{at}namicos.co.jp),
Takashi Amagasa7 (takashi_amagasa{at}terumo.co.jp) and
Kimitaka Misawa8 (kimitaka.misawa{at}shionogi.co.jp)

¹ CM Plus Corporation;
² Mitsubishi Tanabe Pharma Corporation;
³ Kyowa Kirin Co. Ltd.;
⁴ Idorsia Pharmaceuticals Ltd;
⁵ Cytiva;
⁶ Namicos Corporation;
⁷ Terumo Co. Ltd;
⁸ Shionogi Pharma Co. Ltd.

↵* Corresponding author; email: katayama{at}cm-plus.co.jp

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 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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