The Japan Industrial and Medical Gases Association (JIMGA) has founded two working groups to address best practice requirements.
The association recently established two collectives to enable the Ministry of Health, Labour and Welfare to meet requirements of the international Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S).
JIMGA created the Good Manufacturing Practice (GMP) Working Committee for Enhanced Investigation. In addition, the overseeing body also established a specific working group to analyse the efficacy and role of the Convention itself. This group, dubbed, Working Group 5 – Medical Gas Production, is headed by JIMGA.
Members of the former group were selected to analyse GMP related to the production of medical gas and began work in September. Now at a formative stage, the collective is primarily focused upon setting standards to ensure best practice production and high quality products. According to KK Gas Review, the aim is to avoid human error, a lowering of standards, or contamination during the manufacturing process.
JIMGA Director, Naotsugu Kato, outlined, “Basically GMP is not applied to medical gas. However, quite some time ago JIMGA made a GMP template regarding the production of medical gas production plants and filling stations. Now the Ministry of Health, Labour and Welfare is looking into what is in accordance with international standards.”
Kato continued, “JIMGA has been commissioned to undertake an analysis of the discrepancies between these standards, the PIC /S guidelines and the notices in Japan.”
At the beginning of 2011 JIMGA submitted a mid-term report and began work on a commentary which is set for submission during March.