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

Biosafety and Level 4 Laboratories

Released: July 14, 2006 | Volume 5 Issue 2 Pages 70-75

Kazuya YAMAUCHI

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

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

Bernd Renger

The practical protocols on viral clearance study for the application

Released: June 06, 2008 | Volume 9 Issue 1 Pages 6-31

Katsushi MURAI, Tomonari URAKUBO, Yasutake NISHIDA, Enki KOH, Keishin SUGAWARA, Motoyoshi OKAMURA, Masahiro ODA, Osamu KAWAMATA, Kimihiko KOSUGI, Tetsuji SHIOMI, Hideharu TAKAHASHI, Shunsuke TONOMORI, Hideki HAYASHI, Yuichi MARUYAMA

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