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Pharmaceutical good manufacturing practice: Leuplin® production in Japan identifies major international shortcomings
Masahiro Wada1, Akihiko Ozaki2,3, Takashi Miyachi2
1Department of Breast Surgery, Sano Kosei General Hospital, 1728 Horigomecho, Sano, Tochigi, 327-8511, Japan. rope@helen.ocn.ne.jp.
Abstract:
In Japan, the production of Leuplin®, a key drug for the treatment of prostate cancer and breast cancer, was temporarily suspended in 2020 by the manufacturer. The incident illustrated several significant failings, namely the lack of uniformity in international GMP (Good Manufacturing Practice) regulations, the lack of mechanisms to resolve disputes between PIC/S (Pharmaceutical Inspection Co-operation Scheme) member countries, and the importance of maintaining a stable supply of safe GMP-compliant essential medicines.
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