Umgang mit Out of Specification (OOS)—Resultaten auf Laborebene

Released: December 04, 2009 | Volume 10 Issue 2 Pages 43-53

Bernd Renger

Manufacturing Environmental Control for Non-sterile Pharmaceutical Dosage Forms Establishment of Risk-based Control and Maintenance Systems

Released: August 12, 2015 | Volume 17 Issue 1 Pages 5-93

Keisuke INOUE, Yoshimi URAYAMA, Tsutomu KAMIKUKITA, Toshimitsu SHIRAI, Osamu SHIROKIZAWA, Tokuhito SUGIYAMA, Masao SUDOH, Hironori TANAKA, Shigehiro TAHARA, Masumi NASUKAWA, Shigeto HIRABARA, Taku HORIE, Hiroshi MITSUYOSHI, Hiromi MIHARA, Takayuki MIYAMOTO, Daikichiro MURAKAMI, Kuniaki YAMANAKA

[title in Japanese]

Released: July 23, 2011 | Volume 12 Issue 2 Pages 70-77

Case Studies on How to Handle Deviations
~Points to be Considered for a More Appropriate Handling~

Released: May 10, 2007 | Volume 8 Issue 1 Pages 78-86

Kenichi TAKEZAWA, Hirohito KATAYAMA, Hironori TANAKA, Keishiro TAMURA, Misako NAKAMURA, Shoichi MIYAKE, Tetsuo MUROI, Masashi MOMONAGA, Takashi YAMAOKA, Toshiya WAKUDA

Points to consider in quality assurance of biotechnology product manufacturing by using single-use systems

Released: December 21, 2017 | Volume 19 Issue 2 Pages 15-29

Akiko ISHII-WATABE, Noritaka HASHII, Mariko MATSUMOTO, Noriko KATORI, Susumu ARAI, Hirotoshi AWATSU, Tetsuya ISONO, Tomomi INOUE, Akira EIZA, Yukihito OOYAMA, Takehiro OKUMURA, Daisuke KAJIHARA, Shinya TAKUMA, Kouichi TANGE, Masayoshi TSUKAHARA, Maiko TSUTSUI, Iyo TERASHIMA, Taishiro NAKAGAWA, Hideshi HATTORI, Shinsuke HAYASHI, Yoshiaki HARA, Hiroyuki MATSUDA, Sei MURAKAMI, Takahiro YANO, Masahiro IWAKURA, Takeshi OMASA, Nana KAWASAKI, Akihiko HIROSE