中国、美国及欧盟GMP（官网下载）.rar

[{"title":"（ 35 个子文件 5.76MB ） 中国、美国及欧盟GMP（官网下载）.rar","children":[{"title":"中国、美国及欧盟GMP（官网下载）","children":[{"title":"欧盟GMP","children":[{"title":"part1","children":[{"title":"chap6 Quality Control2014-11.pdf <span style='color:#111;'> 44.03KB </span>","children":null,"spread":false},{"title":"chap1 Pharmaceutical Quality System_2013-01_.pdf <span style='color:#111;'> 64.30KB </span>","children":null,"spread":false},{"title":"chap5 Production.pdf <span style='color:#111;'> 285.28KB </span>","children":null,"spread":false},{"title":"chap9 SELF INSPECTION.pdf <span style='color:#111;'> 10.07KB </span>","children":null,"spread":false},{"title":"chap7 Outsourced Activities 2012-06.pdf <span style='color:#111;'> 20.62KB </span>","children":null,"spread":false},{"title":"chap2 Personnel-2014-03_.pdf <span style='color:#111;'> 57.46KB </span>","children":null,"spread":false},{"title":"chap4 01-2011_Documentation.pdf <span style='color:#111;'> 32.53KB 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for the 'written confirmation' for active substances exported to the European.pdf <span style='color:#111;'> 486.80KB </span>","children":null,"spread":false},{"title":"Internationally harmonised requirements for batch.pdf <span style='color:#111;'> 100.31KB </span>","children":null,"spread":false},{"title":"2011_site_master_file_en.pdf <span style='color:#111;'> 32.22KB </span>","children":null,"spread":false}],"spread":true},{"title":"part2","children":[{"title":"Basic Requirements for Active Substances used as Starting Materials.pdf <span style='color:#111;'> 613.94KB </span>","children":null,"spread":false}],"spread":true},{"title":"附录","children":[{"title":"annex09 MANUFACTURE OF LIQUIDS, CREAMS AND OINTMENTS.pdf <span style='color:#111;'> 12.54KB </span>","children":null,"spread":false},{"title":"annex2 Manufacture of Biological active substances and Medicinal Products for Human.pdf <span style='color:#111;'> 475.46KB </span>","children":null,"spread":false},{"title":"annex16 Certification by a Qualified Person and Batch Release.pdf <span style='color:#111;'> 242.13KB </span>","children":null,"spread":false},{"title":"annex6 Manufacture of Medicinal Gases.pdf <span style='color:#111;'> 47.44KB </span>","children":null,"spread":false},{"title":"annex8 SAMPLING OF STARTING AND PACKAGING MATERIALS.pdf <span style='color:#111;'> 19.34KB </span>","children":null,"spread":false},{"title":"annex11 01-2011_ Computerised Systems.pdf <span style='color:#111;'> 21.93KB </span>","children":null,"spread":false},{"title":"annex17 Real Time Release Testing and Parametric Release.pdf <span style='color:#111;'> 315.79KB </span>","children":null,"spread":false},{"title":"annex15 Qualification and Validation.pdf <span style='color:#111;'> 94.17KB </span>","children":null,"spread":false},{"title":"annex19 Reference and Retention Samples.pdf <span style='color:#111;'> 23.09KB </span>","children":null,"spread":false},{"title":"annex1 Manufacture of Sterile Medicinal Products.pdf 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