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日期:2024-09-10
各國為此無不配合推行原料藥GMP 之認證,甚有成立專職機構以應. 對,由此可見,原料藥實施GMP 實為勢在必行之國際趨勢。 藥事法業於101 年6 月27 日修正公告, ......
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日期:2024-09-08
究以問卷調查方式,分別於97年及98年針對國內藥廠執行PIC/S GMP狀況及預計全面符合. 時程進行調查, .... 行調查,相關資訊亦做為規劃查廠排程及人力之. 參考。...
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日期:2024-09-04
作,合稱為PIC/S,目前共有三十三個會員(GMP 稽查權責機關),分屬於三. 十二個 ...
表3-2 PIC 與the Scheme 之主要差異. PIC ..... cGMP 之主要差異處,可分為三個
重點部分加以說明,在硬體設施等方面,....
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日期:2024-09-08
PIC/S annual training seminar 2014 on "Dedicated Facilities: Yes or No?" 22-24 October 2014 - Paris, France > Read more PIC/S annual training seminar 2013 on "Global Supply Chains and GMP Compliance" 9-11 October 2013 - Ottawa, Canada > Read more PIC/S .....
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日期:2024-09-05
Guideline The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have ... EU GMP Annex 19: Reference and Retention Samples Internet: http://www.gmp ......
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日期:2024-09-11
Guideline The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink. EU GMP Chapter 6: Quality Control Internet: http://www.gm...
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日期:2024-09-04
The draft widely refers to PIC/S (Pharmaceutical Inspection Cooperation Scheme) Guidelines.Thus the Australian TGA furthers progress in harmonizing their Guidelines with the PIC/S Documents. Main objectiv of this TGA Guideline is to regulate the GMP ......
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日期:2024-09-08
what is gmp? GMP regulations in pharmaceutical manufacturing production as BMR and other documents. ... Good manufacturing practice (GMP) is a group of guidelines those are regulated by WHO since 1975 throughout the world. The aim of GMP is to ensure the ...