Current status of global harmonization of GMP standards in PIC/S and future prospects of effective GMP inspection by PMDA

The author has been involved in the management of PIC/S since January 2022 as Executive Bureau Member. The current status of global harmonization of GMP standards, the challenges facing PIC/S and the significance of participating in PIC/S activities are described in this review article with the auth...

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Bibliographic Details
Published inPDA Journal of GMP and Validation in Japan Vol. 24; no. 2; pp. 45 - 56
Main Author HARA, Kentaro
Format Journal Article
LanguageJapanese
Published Parenteral Drug Association Japan Chapter 2022
Subjects
Global harmonization
GMP Inspection
PIC/S
Risk Communication
Training
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Summary:The author has been involved in the management of PIC/S since January 2022 as Executive Bureau Member. The current status of global harmonization of GMP standards, the challenges facing PIC/S and the significance of participating in PIC/S activities are described in this review article with the author's personal views. PMDA, Ministry of Health, Labour and Welfare (MHLW) and 47 prefectures of Japan became PIC/S' Participating Authority in 2014. To ensure the quality of medicines distributed on the global market, PIC/S including the PMDA should try to develop more effective GMP regulations.
ISSN:1344-4891
1881-1728
DOI:10.11347/pda.24.45