國內實施 pic/s gmp 國際標準情形及對於用藥品質之影響

*GMP Inspectorate TFDA*PIC/S GMP 99925

GMP Inspectorate TFDA

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*GMP Inspectorate TFDA*


*GMP Inspectorate TFDA*30 Sulfanilamide20diethylene glycol107 1938FDA 602020 Thalidomide201962 - -FDA -GMP


*GMP Inspectorate TFDA* CTDSafetyEfficacyQualityGMP GTP(safety)(efficacy)(quality) GLPGPP/GDPGLP:Good Laboratory Practice GCP:Good Clinical PracticeGDP:Good Distribution Practice GMP:Good Manufacturing PracticeGTP:Good Tissue Practice GPP: Good Pharmacovigilance PracticeGCP


*GMP Inspectorate TFDA* (Good Manufacturing Practice, GMP) Pharmacovigilance


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*GMP Inspectorate TFDA*GMP1962GMP1963 GMPGMPWHO1969 GMP 1975 GMP 1973 GMP 1974 GMP 1980 1982 GMP 1988 GMP


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*GMP Inspectorate TFDA*GMPQuality ControlQuality AssuranceQuality ManagementDesign, Development & ImplementQuality Systems/QA 1970s ~ 2000s


*GMP Inspectorate TFDA* ICH/ PIC/S ()GMP/


*GMP Inspectorate TFDA*ICHestablished in 1990 The International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use6EC EFPIA FDA PhRMAMHLW JPMAICH ObserversWHO EFTA Health CanadaPIC/Sestablished in 1995The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme 37Health Authorities3528PartnersEMAEDQMWHOUNICEFPIC/S GMP GuideGMP


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*GMP Inspectorate TFDA*PIC/S

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*GMP Inspectorate TFDA* 99226 34 PIC/SGuide to Good Manufacturing Practice for Medicinal Products


*GMP Inspectorate TFDA*PIC/S GMP PIC/S GMPGood Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification.


*GMP Inspectorate TFDA*PIC/S GMP (2)Ch1.Ch7.//Ch9.Ch3. Ch2. InputProcessoutputCh5.

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*GMP Inspectorate TFDA*X871907(700 %)(2003)X


*GMP Inspectorate TFDA*(diethylene glycol)(2007)XXHeparinOversulfated Chondroitin78019(2008)


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PIC/S GMP -100%



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*GMP Inspectorate TFDA*http://www.fda.gov.tw/

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GMP



SIQCM20042010.03FDA20052009.08FDA20072008NADFC2008JAZMP2008MOH2009BFD2009TFDA2010.06


*GMP Inspectorate TFDA*To be the world class

TFDAThe Quality Journey is a Voyage, NOT a Destination!Were Committed to our Quality Journey

GMP Inspectorate


*GMP Inspectorate TFDA*TFDAGMP(TFDA)(;http://adr.doh.gov.tw/)(;http://recall.doh.gov.tw/)(;http://dtirs.fda.gov.tw/Mein/Home.aspx?TT=0) (Therapeutic inequivalence)()




****Sulfanilamide20FDA

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*1.2. Common Technical Documents, CTDCMCGood Laboratory Practice, GLPGood Clinical Practice, GCPGMPGood Distribution Practice, GDPGMP******77GMP1st: 89.12.312nd: 91.6.30: 93.6.30*****Industrys becoming more international and seeking new global marketsHarmonization of regulatory*European Commission - European Union (EU)The European Commission represents the 27 members of the EU. The Commission works through harmonisation of legislation and technical requirements and procedures, to achieve a single market in pharmaceuticals to allow free movement of products throughout the EU.The European Medicines Agency (EMEA) has been established by the Commission and is situated in London. Technical and scientific support for ICH activities is provided by the Committee for Medicinal Products for Human Use (CHMP) of the EMEA. European Federation of Pharmaceutical Industries and Associations (EFPIA)EFPIA, is situated in Brussels and has, as its members, 29 national pharmaceutical industry associations and 45 leading pharmaceutical companies involved in the research, development and manufacturing of medicinal products in Europe for human use. Much of the Federation's work is concerned with the activities of the European Commission and the EMEA.A wide network of experts and country coordinators has been established, through Member Associations, to ensure that EFPIA's views within ICH are representative of the European industry.

Ministry of Health, Labour and Welfare, Japan (MHLW)The Ministry of Health, Labour and Welfare has responsibilities for approval and administration of drugs, medical devices and cosmetics in Japan.Technical and scientific support for ICH activities are provided by the Pharmaceuticals and Medical Devices Agency (PMDA) (which was established in April 2004 as a new administrative agency for scientific review for drug approval), and by the National Institute of Health Sciences (NIHS) and other experts from academia.

Japan Pharmaceutical Manufacturers Association (JPMA)JPMA represents 75 members (including 20 foreign affiliates) and 14 committees. Membership includes all the major research-based pharmaceutical manufacturers in Japan.ICH work is coordinated through specialised committees of industry experts who also participate in the Expert Working Groups.Among the objectives of JPMA is the development of a competitive pharmaceutical industry with a greater awareness and understanding of international issues. JPMA promotes and encourages the adoption of international standards by its member companies.

US Food and Drug Administration (FDA)The US Food and Drug Administration has a wide range of responsibilities for drugs, biologicals, medical devices, cosmetics and radiological products. The largest of the world's drug regulatory agencies FDA is responsible for the approval of all drug products used in the USA.The FDA consists of administrative, scientific and regulatory staff organised under the Office of the Commissioner and has several Centers with responsibility for the various products which are regulated. Technical advice and experts for ICH work are drawn from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Pharmaceutical Research and Manufacturers of America (PhRMA)The Pharmaceutical Research and Manufacturers of America - PhRMA - represents the research-based industry in the USA. The Association has 67 companies in membership which are involved in the discovery, development and manufacture of prescription medicines. There are also 24 research affiliates which conduct biological research related to the development of drugs and vaccines.PhRMA, which was previously known as the US Pharmaceutical Manufacturers Association (PMA), coordinates its technical input to ICH through its Scientific and Regulatory Section. Special committees have been set up, of experts from PhRMA companies, to deal with ICH topics.

EMEAEuropean Medicines AgencyEDQMEuropean Directorate for the Quality of Medicines & HealthCareWHOWorld Health OrganizationUNICEFUnited Nations International Childrens Emergency FundPIC/SpartnersPIC/S **Ministry of Health ofIran and the Bureau of Food and Drugs of the Philippines* GMP ****Good Manufacturing Practice , GMP **********************Good Manufacturing Practice , GMP *****PIC/SGMPMr. Robert Tribe97GMPMr. TribeGMPPIC/S *GMPGMPGMPGMPGMPGMPManufacturing LicenseGMPGMP Certificate**GMP*Ministry of Health ofIran and the Bureau of Food and Drugs of the Philippines***