| 초록 |
The Korea Biotechnology Industrialization Center (KBIC) of the Korea Institute ofIndustrial Technology (KITECH) will build a manufacturing facility to meet the CGMPregulations and other national and international standards by 2003. Business scope ofthe KBIC will include manufacturing of clinical and commercial biotechnology productsfor global distribution. The KBIC manufacturing facility will be operated under theCGMP and other applicable regulations, policies, and laws. To facilitate this purpose,appropriate quality system and infrastructure will be established. This documentincludes a facility design features, functional areas, description of each flow, HVACdistribution, critical systems description, clean room classification, room pressurization.
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