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Research ArticleResearch

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
Hirohito Katayama
1CM Plus Corporation, Kanagawa, Japan
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  • For correspondence: katayama@cm-plus.co.jp
Manabu Tsuda
2Mitsubishi Tanabe Pharma Corporation, Osaka, Japan
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Yukari Koga
3Kyowa Kirin Co. Ltd., Tokyo, Japan
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Nobuaki Habasaki
4Idorsia Pharmaceuticals Ltd., Tokyo, Japan
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Kosuke Taniyama
5Cytiva, Tokyo, Japan
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Yuichi Minato
6Kyowa Kirin Co. Ltd., Gunma, Japan
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Akihiro Oda
7Namicos Corporation, Osaka, Japan
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Koichi Nagata
7Namicos Corporation, Osaka, Japan
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Takashi Amagasa
8Terumo Co. Ltd., Tokyo, Japan; and
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Kimitaka Misawa
9Shionogi Pharma Co. Ltd., Osaka, Japan
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References

  1. 1.↵
    U.S. Pharmacopeial Convention. General Chapter <790> Visible Particulates in Injections. In USP 37—NF 32, Supplement 1, USP: Rockville, MD, 2014.
  2. 2.↵
    U.S. Pharmacopeial Convention. General Chapter <1790> Visual Inspection of Injections. In USP 40—NF 35, Supplement 1, USP: Rockville, MD, 2017.
  3. 3.↵
    Council of Europe, Recommendations on Testing of Particulate Contamination: Visible Particles, Chapter 5.17.2. In European Pharmacopoeia (Ph. Eur.), Supplement 10.3, Council of Europe: Strasbourg, France, 2021.
  4. 4.↵
    European Compliance Academy (ECA) Visual Inspection Working Group. Visual Inspection of Medicinal Products for Parenteral Use. In Good Practice Guide, version 3.2; ECA: Heidelberg, Germany, 2020.
  5. 5.↵
    1. Shabushnig J. G.,
    2. Katayama H.
    Japanese Pharmacopeia (JP) and United States Pharmacopeia (USP) Developments in Visual Inspection for Foreign Particulate Matter, PDA J. GMP Validation Japan. 2015, 17 (1), 94–103.
    OpenUrl
  6. 6.↵
    1. Kikuchi T.,
    2. Gotanda K.,
    3. Fujisawa T.,
    4. Noguchi M.,
    5. Okano S.,
    6. Morici A.,
    7. Katayama H.
    Study on Foreign Insoluble Matter Test for Injections-Effects of Inspection Conditions on Detection Rate. Pharm. Med. Device Regul. Sci. 2013, 44 (4), 362–370 (in Japanese).
    OpenUrl
  7. 7.↵
    1. Gotanda K.,
    2. Fujisawa T.,
    3. Kikuchi T.,
    4. Noguchi M.,
    5. Okano S.,
    6. Morici A.,
    7. Katayama H.
    Study on Foreign Insoluble Matter Test for Injections-Study of the Influence of Inspection Conditions on Variability of Detection Rate. Pharm. Med. Device Regul. Sci. 2015, 46 (8), 560–565.
    OpenUrl
  8. 8.↵
    1. Bukofzer S.,
    2. Ayres J.,
    3. Chavez A.,
    4. Devera M.,
    5. Miller J.,
    6. Ross D.,
    7. Shabushnig J.,
    8. Vargo S.,
    9. Watson H.,
    10. Watson R.
    Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2015, 69 (1), 123–139.
    OpenUrlFREE Full Text
  9. 9.↵
    1. Langille S. E.
    Particulate Matter in Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2013, 67 (3), 186–200.
    OpenUrlAbstract/FREE Full Text
  10. 10.↵
    1. Melchore J. A.,
    2. Berdovich D.
    Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection. PDA J. Pharm. Sci. Technol. 2012, 66 (3), 273–284.
    OpenUrlAbstract/FREE Full Text
  11. 11.↵
    U.S. Food and Drug Administration. Draft Guidance for Industry: Inspection of Injectable Products for Visible Particles. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2021.
  12. 12.↵
    1. Knapp J. Z.,
    2. Kushner H. K.
    Generalized Methodology for Evaluation of Parenteral Inspection Procedures. J. Parenter. Drug Assoc. 1980, 34 (1), 14–61.
    OpenUrlPubMed
  13. 13.↵
    1. Katayama H.
    Foreign Matter of Injectables – Development of Standards in Japan, 2014.
  14. 14.↵
    Ministry of Health Labour and Welfare of Japan. General Tests—6.06 Foreign Insoluble Matter Test for Injections. In The Japanese Pharmacopoeia, 18th Edition (English Version), MHLW: Tokyo, 2021; pp 165.
  15. 15.↵
    Parenteral Drug Association Inc. PDA Survey: 2015 Particulate Matter in Difficult to Inspect Parenterals; PDA: Bethesda, MD, 2015.
  16. 16.↵
    Parenteral Drug Association Inc. Technical Report No. 79: Particulate Matter Control in Difficult-to-Inspect Parenterals, Bethesda, MD, 2018.
  17. 17.↵
    1. Johns J.,
    2. Golfetto P.,
    3. Bush T.,
    4. Fantozzi G.,
    5. Shabushnig J.,
    6. Perry A.,
    7. Degrazio F.,
    8. Streich D.,
    9. Miller J.,
    10. Soukiassian H.,
    11. Stanton A.,
    12. Watson R.
    Achieving “Zero” Defects for Visible Particles in Injectables. PDA J. Pharm. Sci. Technol. 2018 72, (6), 640–650.
    OpenUrlAbstract/FREE Full Text
  18. 18.↵
    1. Tsuda M.
    Standardization of Visual Inspection Capability for Injections, Tokyo, 2017
  19. 19.↵
    1. Okano S.
    Pharmaceutical Product Quality Testing, Tokyo, 2019.
  20. 20.↵
    1. Katayama H.
    How a Standardized Calibration Is Useful to See Operator’s Unique Capability in Manual Visual Inspection. 2021 PDA Aseptic Processing of Biopharmaceuticals Virtual Conference, Virtual, Oct 19–21, 2021.
  21. 21.↵
    1. Aldrich D. S.,
    2. Cherris R. T.,
    3. Shabushnig J. G.
    ; Visual Inspection and Particulate Control, Davis Healthcare International Publishing: River Grove, IL, 2016.
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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 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, 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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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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Keywords

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

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