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Good Practices

ISPE

www.ispe.org
Engineering Pharmaceutical Innovation
International Society for Pharmaceutical Engineering

GAMP®

www.ispe.org/gamp
GAMP® Community of Practice (COP): Good Automated Manufacturing Practice
Compliant GxP computerized systems

Regulatory entities

ICH

www.ich.org
International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

PIC
PIC/S

www.picscheme.org
Pharmaceutical Inspection Convention
Pharmaceutical Inspection Cooperation Scheme

WHO

www.who.int
World Health Organization

EMA

www.ema.europa.eu
European Medicines Agency

ANSM (formerly AFSSAPS)

www.ansm.sante.fr
Agence nationale de sécurité du médicament et des produits de santé
French Health Products Safety Agency

ANSES - ANMV

www.anmv.anses.fr
Agence nationale du médicament vétérinaire
French Agency for Veterinary Medicinal Products

NoMA

www.noma.no
Statens legemiddelverk: Norwegian Medicines Agency

Swissmedic

www.swissmedic.ch
Swiss Agency for therapeutic products

ZLG

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

FDA

www.fda.gov
US Food and Drug Administration

MHLW

www.mhlw.go.jp/english/
Ministry of Health, Labour and Welfare (Japan)

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Last update: 2017-01-01

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