Since 2006 12 2007 2008 2009 2010 OECD

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Since 2006年 12月 2007 2008 2009 2010 OECD GLP 國家符合性 監控系統 2

Since 2006年 12月 2007 2008 2009 2010 OECD GLP 國家符合性 監控系統 2

OECD Council Acts related to GLP - 1989 MAD (Mutual Acceptance of Data) COUNTRY

OECD Council Acts related to GLP - 1989 MAD (Mutual Acceptance of Data) COUNTRY A COUNTRY B Submit s Data REGULATORY AUTHORITY TEST FACILITY Information Requests Information on GLP Compliance Status of the Laboratory or Study Audit Inspection and/or Study Audit Information Report GLP MONITORING AUTHORITY Requests Information 3

申請技術類別 01 物理─化學測試 (Physical-chemical testing) 05 水、土壤、空氣內行為試驗 (Studies on behavior in water, soil and

申請技術類別 01 物理─化學測試 (Physical-chemical testing) 05 水、土壤、空氣內行為試驗 (Studies on behavior in water, soil and air ); 生物累積作用(bioaccumulation) 02 毒性試驗 (Toxicity studies) 06 殘留試驗 (Residues studies) 03 致變異性試驗 (Mutagenicity studies) 04 水域與陸域生物之環境毒性試驗 (Environmental toxicity studies on aquatic and terrestrial organisms) 07 模擬生態池及自然生態系統效應 (Studies on effects on mesocosms and natural ecosystems) 08 分析性及臨床化學測試 (Analytical and clinical testing ) 09 其他試驗(如藥害試驗或參考OECD 化學品測試指引) 6

Test facility GLP Inspector WHO INSPECTS, AUDITS OR MONITORS WHAT? QA 11

Test facility GLP Inspector WHO INSPECTS, AUDITS OR MONITORS WHAT? QA 11

網頁資訊 www. taftw. org. tw 13

網頁資訊 www. taftw. org. tw 13

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l AAALAC 認證 進階生物科技股份有限公司 l Capacity : 51 間飼育房 臨床前試驗中心 CRO Services l Specific

l AAALAC 認證 進階生物科技股份有限公司 l Capacity : 51 間飼育房 臨床前試驗中心 CRO Services l Specific Pathogen Free (SPF) 5 F-Rabbit & Dog Study 5 F 4 F –Rodent (Long Term) 4 F 3 F 2 F 3 F –Rodent (Short Term) 1 F 2 F –Supporting Area 1 F 18 –Cadaver Storage Room 18