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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;
Manabu Tsuda
2 Mitsubishi Tanabe Pharma Corporation;
Yukari Koga
3 Kyowa Kirin Co. Ltd.;
Nobuaki Habasaki
4 Idorsia Pharmaceuticals Ltd;
Kosuke Taniyama
5 Cytiva;
Yuichi Minato
3 Kyowa Kirin Co. Ltd.;
Akihiro Oda
6 Namicos Corporation;
Kouichi Nagata
6 Namicos Corporation;
Takashi Amagasa
7 Terumo Co. Ltd;
Kimitaka Misawa
8 Shionogi Pharma Co. Ltd.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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
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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