【原创】日本GMP简介

……However, under the revision to and enforcement of the Pharmaceutical Affairs Law of April 1, 2005, there has been issued a new MHLW Ordinance relating to Standards for Manufacturing Control and Quality Control for Drugs and Medical Devices (MHLW Ordinance No. 179, December 24, 2004), thereby integrating GMP hardware rendered necessary by the characteristics of drugs with GMP software.  Specifically, Article 9 establishes basic standards for the buildings and facilities of manufacturing plants where GMP is applicable, and Article 23 establishes standards for the buildings and facilities of manufacturing plants for sterile drugs.
（摘自：Pharmaceutical Administration and Regulations in Japan (INFORMATION IN ENGLISH ON JAPAN REGULATORY AFFAIRS, 2009.3)，做日本注册一定要看。)http://www.jpma.or.jp/english/parj/whole.html

日本除了GMP外，还有GQP（Q是Quality Assurance）、QMS等，在MHLW Ministerial Ordinances on GQP and GMP 2005中列出了4个厚生省令（The whole text of these four MHLW Ministerial Ordinances Established/Revised in 2004/2005）:
◆　Standards for Quality Assurance of Drugs, Quasi-drugs, Cosmetics and Medical Devices（文字版）
　　[GQP Ministerial Ordinance]
　　(MHLW Ministerial Ordinance No. 136 Established as of September 22, 2004)
◆　Regulations for Buildings and Facilities for Pharmacies etc.（文字版）  
　　[Buildings and Facilities Regulations]  
　　(MHLW Ministerial Ordinance No. 180 Revised as of December 24, 2005)
◆　Standards for Manufacturing Control and Quality Control of Drugs and Quasi-drugs（文字版用Nuance OmniPage 17识别）
　　[GMP Ministerial Ordinance on Drugs and Quasi-drugs]
　　(MHLW Ministerial Ordinance No. 179 Revised as of December 24, 2004)
◆　Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostics（文字版）
　　[QMS Ministerial Ordinance on Medical Devices and In Vitro Diagnostics]
　　(MHLW Ministerial Ordinance No. 169 Revised as of December 17, 2004)

在The Japanese GMP Regulations 2003中还列出以下相关厚生省令和通知（The Ministry of Health, Labour and Welfare (MHLW) Ministerial Ordinances and MHLW Director-General Notification related to the Japanese GMP for Drugs are）：
■　Regulations for Buildings and Facilities for Pharmacies, etc. (MHW Ministerial ordinance No. 2 dated Februaryl , 1961; Amended: MHLW Ministerial Ordinance No. 92 dated May 20 , 2003)
■　Regulations for Manufacturing Control and Quality Control of Drugs (MHW Ministerial ordinance No. 16 dated March 12 , 1999; Amended: MHLW Ministerial Ordinance No. 95 dated May 20, 2003)
■　Regulations for Importing/Retail Management and Quality Control of Drugs and Quasi-drugs (MHW Ministerial Ordinance No. 62 dated June 2, 1999; Amended: MHLW Ministerial ordinance No. 97 dated May 20, 2003)
■　MHLW Ministerial Ordinance on the Manufacturing Control and Quality Control When Manufacturing of a Single Product of the Drugs, Quasi-drugs, Cosmetics and Medical Devices Specified under Article 1-2-2, Paragraph 1, Items 1, 2 and 4 of the Enforcement ordinance of the Pharmaceutical Affairs Law is Performed at Two or More Manufacturing Sites (MHW Ministerial Ordinance NO. 26 dated March 30, 1994; Amended: MHLW Ministerial Ordinance No. 93 dated May 20, 2003)
■　Good Manufacturing Practice Guide for Active Pharmaceutical ingredients (PFSB Director-General Notification No. 1200 dated November 2, 2001)

另外还有：
Radiopharmaceuticals Manufacturing and Handling Regulations
(MHW Ordinance No. 4, 1961)

官方网站：
http://www.pmda.go.jp/english/service/ministerial.html
http://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0001.html
http://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0002.html
认定外国制造业者列表：http://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0003.html

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