ＧＭＰの国際動向と日本企業の海外活動

  Harmonization of GMP has been intensively discussed in ICH, and the result is expected to emerge by the end of this year. Such kind of international harmonization is a pressing issue in the pharmaceutical industries, since the development of technology sometimes causes de-harmonization of regulations in various counties and area. Harmonization of regulations for pharmaceuticals have significance in deploying the worldwide research and development of new pharmaceuticals effectively. According to the harmonization of regulations for pharmaceuticals, activities of pharmaceutical industries have become rapidly global. In the area of quality control, “How to establish specifications” has been discussed in Q6A, and “Skip test,” “Process control” and “Parametric release” have reached to the agreement. These subjects were firstly discussed in the Joint Conference of Japan PDA and Association of Japan Pharm. Sci. in 1997 in Japan. “Parametric Release” has a close relation with validation, or it is a natural consequence of validation. It can be said, “Where there is Validation, there is Parametric Release. It should not be limited to “Sterility Test”, but should be applied to all of other specifications to determine the quality. As future issues of GMP in Japan, “Consultant” in ICH GMP Section 3(6), and FDA GMP Section 211-34 should be discussed in Japan, since there is no this section in Japan GMP. “Contract Manufacturing and Contract Laboratory” should also be discussed in future in Japan, since the concept of “Contract” is very much limited in the Japan GMP. “Complaint and Recall” should also be discussed from the view points of “Safety”, and results should be informed to the world with sound basis of safety. GMP inspection system should also be discussed in the world, after the agreement of written GMP. There seems to be significant differences in the written GMP, but there seems to be much differences in the implementation of GMP between men to men, area to area, country to country. Audit experiences of ISO 9000s show the importance of worldwide auditors' training. CTD (Common Technical Document), and various kinds of ISO Technical Requirements would have much influence to GMP. We have to watch these discussions. Under these circumstances, pharmaceutical industries in Japan are now expanding their activities from domestic to the world.<br>