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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, Koichi Nagata, Takashi Amagasa and Kimitaka Misawa
PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 178-192; DOI: https://doi.org/10.5731/pdajpst.2023.012911

Article Information

vol. 79 no. 2 178-192
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 
  • Published online May 14, 2025.

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Copyright & Usage 
© PDA, Inc. 2025

Author Information

  1. Hirohito Katayama1,*,
  2. Manabu Tsuda2,
  3. Yukari Koga3,
  4. Nobuaki Habasaki4,
  5. Kosuke Taniyama5,
  6. Yuichi Minato6,
  7. Akihiro Oda7,
  8. Koichi Nagata7,
  9. Takashi Amagasa8 and
  10. Kimitaka Misawa9
  1. 1CM Plus Corporation, Kanagawa, Japan
  2. 2Mitsubishi Tanabe Pharma Corporation, Osaka, Japan
  3. 3Kyowa Kirin Co. Ltd., Tokyo, Japan
  4. 4Idorsia Pharmaceuticals Ltd., Tokyo, Japan
  5. 5Cytiva, Tokyo, Japan
  6. 6Kyowa Kirin Co. Ltd., Gunma, Japan
  7. 7Namicos Corporation, Osaka, Japan
  8. 8Terumo Co. Ltd., Tokyo, Japan; and
  9. 9Shionogi Pharma Co. Ltd., Osaka, Japan
  1. ↵* Corresponding Author: CM Plus Corporation, Minatomirai 4-6-2, Nishi-ku, Kanagawa, Japan; Telephone: +81 80-5944-6726; E-mail: katayama{at}cm-plus.co.jp
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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, Koichi Nagata, Takashi Amagasa, Kimitaka Misawa
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 178-192; DOI: 10.5731/pdajpst.2023.012911
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