台灣藥廠GMP管理政策與現況GMP Policy in Taiwan - 中華民國醫師 ... 1962年，美國修訂「食品藥物化妝品法案」，開始要求藥廠實施GMP，確保藥品品質。 ..... 香港XX藥業生產的痛風藥「allupurinol」驗出毛黴菌，含菌量超出標準100倍；有 ...
原料藥GMP - 衛生福利部食品藥物管理署 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 ...
PIC/S 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 ..
PIC/S PIC/S' mission is "to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and ...
第一部、附則 - 衛生福利部食品藥物管理署 於2009 年9 月1日（PE009-9）公布之PIC/S GMP Guide 第一部（Part I）與附則（ Annex. 1,2,3,6,8,9,10,11,12 .... 管制及放行的法規之要求生產與管制. 前，該藥品 不得 ...
Current Global GMP Status and Trends With Focus on EU & PIC/S 7 EudraLex Vol 4 (EU – GMP) GMP-Guidelines based on Dir 2003/94/EC and 91/411/EEC (EudraLex Vol. 4: ‘EU-GMP’) Chapter 1-9 ICH Q7 & ICH Q9 principles ICH Q9, ICH Q10, SMF, Batch certificate Annex 1-17;19 GDP guideline; comp. of comm.procedures
GMP Guideline EU GMP Annex 19: Reference and Retention Samples 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 ...
GMP Guideline EU GMP Annex 15: Qualification and Validation 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 Annex 15: Qualification and Validation Internet: h
New Australian Guideline (TGA) - GMP Publishing - GMP/cGMP (current Good Manufacturing Practice 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 ...
Compilation of Community Procedures on Inspections and Exchange of Information Table of Contents: Introduction 4 Quality Systems Framework for GMP Inspectorates 5 Procedures Related to Rapid Alerts 14
