PDA Journal of GMP and Validation in Japan

PDA Journal of GMP and Validation in Japan

Published by Parenteral Drug Association Japan Chapter

270 registered articles
(updated on August 07, 2026)

Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891

JOURNAL PEER REVIEWED FREE ACCESS

2026 Volume 28 Issue 1

Data and AI Enablement in Pharmaceutical CMC Manufacturing: Challenges, Use Cases, and Talent Strategy Akito DAIBA
Challenges and Practical Approaches to Environmental Monitoring Based on PIC/S GMP Annex1 Sterile Products GMP Committee, PDA Japan Chapter, Yuto ARIMA, Motoshi HIRAI, Makoto KAWASAKI, Takuji IKEDA, Natsuki TANIGAWA, Masahiro FURUTA, Yasuhito IKEMATSU
The Relationship Between Knowledge Management and AI: A New Perspective on the Handling of Tacit Knowledge —The Role of Tacit Knowledge in Knowledge Management and the Role of AI— PDA Japan Chapter, Technical Education Committee, Akio IMAI
Digital Talent Development for Digital Transformation (DX) in Pharmaceutical Manufacturing PDA Japan Chapter, DX Group in Kansai Study Group, Kenji TAKAI, Shigeki TOGE, Hirotsugu ATSUMARU, Tsutomu KAMIKUKITA, Hironori OCHIAI, Takuro KAYA, Kenta GOTO, Osamu SHIROKIZAWA, Jun NAKAJIMA, Hidetaka HOKAO, Kazuhide YAMAMOTO, Norio YANAGISAWA

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Most viewed articles (July 2026)

1

The Correlation of GQP, GVP and GMP to Quality Assurance for Drugs

Released on J-STAGE: July 07, 2006 | Volume 7 Issue 1 Pages 38-43

Yuji ISHII
2

Challenges and Practical Approaches to Environmental Monitoring Based on PIC/S GMP Annex1

Released on J-STAGE: June 30, 2026 | Volume 28 Issue 1 Pages 70-78

Sterile Products GMP Committee, PDA Japan Chapter, Yuto ARIMA, Motoshi HIRAI, Makoto KAWASAKI, Takuji IKEDA, Natsuki TANIGAWA, Masahiro FURUTA, Yasuhito IKEMATSU
3

Data and AI Enablement in Pharmaceutical CMC Manufacturing: Challenges, Use Cases, and Talent Strategy

Released on J-STAGE: June 30, 2026 | Volume 28 Issue 1 Pages 8-18

Akito DAIBA
4

Visual Inspection Program for Insoluble Particulate Matter by the Japan PDA Pharmaceutical Society and Its Future Prospects

Released on J-STAGE: June 30, 2026 | Volume 28 Issue 1 Pages 34-44

Sterile Products GMP Committee, PDA Japan Chapter, Yoshihiro SUGIURA, Yukari KOGA, Yuki KANEKO, Noriaki HABASAKI, Kimitaka MISAWA, Yasuhito IKEMATSU
5

Issues in ICH Q2(R2)/Q14 and Case Studies on ATP Setting and Risk Management When Applying QbD to Analytical Procedures for Biopharmaceuticals

Released on J-STAGE: June 30, 2026 | Volume 28 Issue 1 Pages 25-33

Hiroko SHIBATA, Akiko ISHII-WATABE

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