Research ArticleResearch
Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan
Shiho Takahashi, Tetsuhito Takarada, Riho Kitamura, Mayumi Shikano and Shingou Sakurai
PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 45-69; DOI: https://doi.org/10.5731/pdajpst.2022.012824
Shiho Takahashi
Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan
Tetsuhito Takarada
Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan
Riho Kitamura
Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan
Mayumi Shikano
Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan
Shingou Sakurai
Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan

References
- 1.↵
- Tobita Y.,
- Yamamoto G.,
- Kudou T.,
- Yamoto T.
- 2.↵Ministry of Health, Labour and Welfare.Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices 1960, Act No.145. https://www.mhlw.go.jp/web/t_doc?dataId=81004000&-dataType=0&pageNo=1 (accessed July 1, 2023)
- 3.↵Ministry of Health, Labour and Welfare. Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs. 2004, Ministerial Ordinance No.179. https://www.mhlw.go.jp/web/t_doc?dataId=81aa6647&dataType=0&pageNo=1 (accessed July 1, 2023)
- 4.↵Ministry of Health, Labour and Welfare. Promulgation of the Act for Partial Amendment of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PSEHB Notification No. 1204 (1) dated December 4, 2019, Issued by the Director of Pharmaceutical Safety and Environmental Health Bureau, the Ministry of Health, Labour and Welfare). https://www.mhlw.go.jp/web/t_doc?dataId=00tc4641&dataType=1&pageNo=1 (accessed November 25, 2023)
- 5.↵Ministry of Health, Labour and Welfare. Partial amendment to the Ministerial Ordinance on Standard for Manufacturing Control and Quality Control for Drugs and Quasi-Drugs. 2021, Ministerial Ordinance No.90. https://www.mhlw.go.jp/web/t_doc?dataId=00tc5900&dataType=1&pageNo=1 (accessed November 25, 2023)
- 6.↵Ministry of Health, Labour and Welfare. Notification No.0702-5 of the PED/PSEHB, No.0702-5 of the CND/PSEHB July 2, 2021. https://www.mhlw.go.jp/hourei/doc/tsuchi/T210706I0010.pdf (accessed October 2022)
- 7.↵International Conference on Harmonisation. Harmonised Tripartite Guideline: Pharmaceutical Quality System Q10. https://www.pmda.go.jp/files/000156592.pdf (accessed July 1, 2023)
- 8.↵Ministry of Health, Labour and Welfare. [Iyakuhin ni kakaru tachiiri kensa tou no tettei ni tsuite.] Notification No.0115-4 of the CND/PSEHB (January 15, 2016).
- 9.↵
- Patel P.,
- Baker D.,
- Burdick R.,
- Chen C.,
- Hill J.,
- Holland M.,
- Sawant A.
- 10.↵Chemo-Sero-Therapeutic Research Institute (Kaketsuken). Investigation Report. November 25, 2015. https://www.mhlw.go.jp/file/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka/0000106165.pdf (accessed July 1, 2023)
- 11.↵
- Kiyohara T.,
- Mimura M.,
- Hirao S.
- 12.↵
- Srinivasan A.,
- Kurey B.
- 13.↵National Institute of Public Health. No. 202125016A. https://mhlw-grants.niph.go.jp/project/159398 (accessed July 1, 2023)
- 14.↵
- Hiroshi F.,
- Katsuhiko S.,
- Yuka N.,
- Mitsutoshi Y.,
- Ikuyo Y.
- 15.↵Japan Generic Medicines Association. Regarding the Initiatives for Trust Recovery in Generic Medicines. Mar 26, 2021. https://www.jga.gr.jp/news/210326_004466.html (accessed July 1, 2023)
- 16.↵
- Friedli T.,
- Buess P.,
- Köhler S.
- 17.↵
- Yu L. X.,
- Kopcha M.
- 18.↵Quality Culture and Its Measurement. https://www.pda.org/pda-europe/news-archive/full-story/2015/01/30/quality-culture-and-its-measurement (accessed July 1, 2023).
- 19.↵Data Integrity–Focus on Quality Culture. https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/XXXustralia/data-integrity–-focus-on-quality-culture.pdf?sfvrsn=d89b6381_4 (accessed July 1, 2023)
- 20.↵
- 21.↵
- Buell R. W.
- 22.↵
- Scholten W.,
- de Vries F.,
- Besieux T.
- 23.↵
- Sucher S. J.,
- Gupta S.
- 24.↵Questionnaire Results Regarding Reliability Assurance Confirmation (Analysis of Corporate Culture) (in Japanese). https://www.jga.gr.jp/assets/uploads/2021/50189f5b2548f3afb4c445780464205e372f2713.pdf (accessed July 1, 2023)
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 1
January/February 2024
Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan
Shiho Takahashi, Tetsuhito Takarada, Riho Kitamura, Mayumi Shikano, Shingou Sakurai
PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 45-69; DOI: 10.5731/pdajpst.2022.012824
Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan
Shiho Takahashi, Tetsuhito Takarada, Riho Kitamura, Mayumi Shikano, Shingou Sakurai
PDA Journal of Pharmaceutical Science and Technology Jan 2024, 78 (1) 45-69; DOI: 10.5731/pdajpst.2022.012824
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