Net-mesh of GMP – cGMP

1.      Net-mesh of GMP

At present, many countries and international organizations have established various GMPs, which seemed to be the net-mesh spreading throughout the world to protect the safety of pharmaceutical products. Like the United States and European Union, the advanced countries of innovative drugs led the trends of GMP developments. So, the United States’ cGMP and European Union’s EU GMP are particularly important. Together with Japan’s GMP, now we call it the “GMP trio”. For manufacture and market of pharmaceutical products, the related permissions must be granted from the national authority. If pharmaceutical products are to be sold in the United States or EU, the manufacture should comply with cGMP or EU GMP. Facilities for manufacturing globally distributed products are required to comply with the GMP trio. However, even the facilities of products only for domestic marketing are often required to comply with the GMP trio. This is because some manufacturers aim to get ready for global standards in view of the ongoing trend of GMP harmonization.

ICH is the international organization working out the harmonization of pharmaceutical regulations including GMP. It is constituted of pharmaceutical regulatory authorities and industry representatives from Japan, the United States and EU, and the observers from 3 organizations, the WHO, Ministry of Health of Canada, and the European Free Trade Association (EFTA). In order to reduce inefficiency of drug development and application for approval caused by different standards for new drug approval and the possibly fast access to the necessary pharmaceutical products by patients among EU, the United States and Japan, guidelines concerning the data collection relating to quality, efficacy, safety needed for drug approval have been established and published.

If the guidelines have been harmonized ICH, each country will be able to act accordingly once completed the due diligence proceeding by national authority, including legislation. The Guidelines harmonized by ICH will be notified by the Pharmaceutical and Food Safety Bureau of MHLW in Japan.

2.      ‘Current’ GMP.

Among all the GMPs over the world, United States’ cGMP leads the world trends and attracts the most global attentions. Because ‘c’ of cGMP stands for ‘current’, cGMP means the GMP that is the latest one. It is symbolized by the policy that GMP should be updated to reflect the latest situation because manufacturing technology always evolves with scientific technology development.

Where ‘current’ means very important. You should not say there is no issue with GMP because our manufacture already met the requirements of GMP last year. It is necessary to actively introduce new advanced technology and scientific knowledge to improve quality continuously for the construction of the pharmaceutical manufacturing facilities compatible to cGMP.