Good Practices
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ISPE
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www.ispe.org
Engineering Pharmaceutical Innovation
International Society for Pharmaceutical Engineering
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GAMP®
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www.ispe.org/gamp
GAMP® Community of Practice (COP): Good Automated Manufacturing Practice
Compliant GxP computerized systems
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Regulatory entities
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ICH
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www.ich.org
International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
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PIC
PIC/S
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www.picscheme.org
Pharmaceutical Inspection Convention
Pharmaceutical Inspection Cooperation Scheme
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WHO
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www.who.int
World Health Organization
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EMA
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www.ema.europa.eu
European Medicines Agency
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ANSM (formerly AFSSAPS)
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www.ansm.sante.fr
Agence nationale de sécurité du médicament et des produits de santé
French Health Products Safety Agency
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ANSES - ANMV
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www.anmv.anses.fr
Agence nationale du médicament vétérinaire
French Agency for Veterinary Medicinal Products
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NoMA
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www.noma.no
Statens legemiddelverk (SLV): Norwegian Medicines Agency
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Swissmedic
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www.swissmedic.ch
Swiss Agency for therapeutic products
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ZLG
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www.zlg.de
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (Germany)
Central Authority of the Laender for Health Protection with Regard to Medicinal Products and Medical Devices
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MHRA
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www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Medicines and Healthcare products Regulatory Agency (UK)
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US FDA
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www.fda.gov
US Food and Drug Administration
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MHLW
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www.mhlw.go.jp/english/
Ministry of Health, Labour and Welfare (Japan)
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