PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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Biosafety Guidelines at Biological Substance Production Facilities
Toshihiko KOMATSU
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2001 Volume 3 Issue 1 Pages 8-12

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Abstract

  In recent years, in Japanese society, Medical practice, medicines, foods, and environmental accidents and natural disasters have been happening. The importance of “Danger management” has been realized, and its system has been strongly sought. On the other hand, even about contagious diseases, treatment with sulfa drugs and/or antibiotics, and inoculation with vaccines have advanced in development. In the developed countries, contagious disease had been thought to be almost conquered. Nevertheless, in the past 20 years about 30 new infectious diseases have appeared, and the previous diseases also have gained immunity to medicines by changing character and virology, reappearing as new diseases and are looked upon as problems. Especially concerning infectious diseases, the importance of controlling dangers such as HIV infected blood plasma goes without saying. With this background, concerning the increasingly sought biosafely, biological production facilities biohazards counterplans sighted as basic lectures are to be conducted. The lecture content is dealing with biohazards, and biosafety principles and practices, and biosafety guideline in bioproduction facilities.

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© 2001 Parenteral Drug Association Japan Chapter
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