韩国动物用医药品等的制造业、进口与销售业的设施基准令(Benchmark facilities for the manufacturing, import and marketing of animal products such as Korea).doc
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韩国动物用医药品等的制造业、进口与销售业的设施基准令(Benchmark facilities for the manufacturing, import and marketing of animal products such as Korea)
韩国动物用医药品等的制造业、进口与销售业的设施基准令(Benchmark facilities for the manufacturing, import and marketing of animal products such as Korea)
Standard order for facilities used in the manufacture, import and sale of pharmaceuticals such as animals
(issued by the Ministry of agriculture, forestry, August 28, 2000)
Article 1: Purpose
6 the provisions of this law pursuant to the provisions of article seventy-second of pharmacy and the law sixteenth third, twenty-sixth second, thirty-fourth third and thirty-seventh in the first paragraph of the provisions, matters related to manufacturing, medicine for animal health products in the import and sale of the industry benchmark facilities. amendment 2000.8.28
Second: definition
The terms used in this regulation are defined as follows: Amendment 2000.8.28
1, animal use of medicinal products refers to animals for medicinal products, animal medical supplements and animal medical equipment.
2, separation means the use of walls to separate into other places.
3, segmentation refers to the use of separation boards and other storage.
4, distinction refers to can not be linked together, separated from each others state.
Third: animal facilities for pharmaceutical plants benchmark
Animals used in pharmaceuticals, workshops and facilities shall comply with the following criteria: Amendment 1996, 8.82000.8.28
1, should have made the workplace (hereinafter referred to as the workplace), shall meet the conditions of the small benchmark production places;
(1) delete 2000.8.28
(2) should be separated from the permanent place;
(3) the area should be more than 100 square meters, which can not affect the operation of drugs. If the production of more than 10 kilograms of packaging unit preparation, its production site should be more than 200 square meters; if the production of biological agents, its production site should be 480 square meters or more;
(4) each should be separated from sterile preparations (including injection, eye drops and eye ointment,
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