GMP LINKS

GMP Links

Authorities Asia

China: SFDA, China

India: Central Drugs Standard Control Organization, Directorate General of Health Service, Ministry of Health and Family Welfare, Government of India

India: Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products (Schedule M)

Authorities Europe (EU)

EMA Documentation Service

EMA history and description

EMA NEWS

EMA: Concept Paper on Storage Conditions during Transport

EU GMP Guide, Chapter 6, Quality Control - Concept Paper

EU-GMP-Guidelines

EU-Pharmacopeia (Ph.Eur.) - online-Version

European Commission Enterprise DG Pharmaceuticals

World Health Organization (WHO) Regional Office for Europe

Authorities European Countries East

Bulgarian Drug Agency

Czech Republic: State Institute for Drug Control

Hungary: National Institute of Pharmacy

Lithuania: State Medicines Control Agency

Romania: National Medicines Agency

Authorities European Countries Middle

Austria: Bundesministerium für Gesundheit, Familie und Jugend

Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Germany: Bundesministerium für Gesundheit - Bonn und Berlin

Germany: Bundeszentrale für gesundheitliche Aufklärung (BZgA)

Germany: Deutsches Institut für Medizinische Dokumentation und Information (DIMDI)

Germany: Paul-Ehrlich-Institut (PEI)

Germany: Robert Koch Institut

Germany: Zentrale Gesundheitsbehörde der Länder (ZLG)

Switzerland: Bundesamt für Gesundheit

Switzerland: Swissmedic Schweizerisches Heilmittelinstitut(früher: Interkantonale Kontrollstelle für Heilmittel (IKS))

Authorities European Countries North

Danish Medicines Agency

Finland: Medicines Agency - Fimea

Iceland: The Icelandic Medicines Control Ag.

Norway: Norwegian Medicines Control Authority

Sweden: Medical Products Agency

Authorities European Countries South

Greece: Adverse Drug Reactions Section

Italy: Ministero della Salute

Malta: Medicines Regulatory Unit

Portugal: National Authority of Medicines and Health Products

Spanish Medicines and Health Products Agency

Authorities European Countries West

Belgium: Pharmac. Inspectorate, Fed. Ministry ...

France: Ministère de la santé et des sports

Irish Medicines Board

Netherlands: Stichting Landelijke Registratie Bij.

UK: Medicines and Healthcare products Reg. Agency

Authorities International
World Health Organization Headquarters Office in Geneva (HQ)
Authorities North America

21 CFR

FDA - Computerized System and Software Development Terminology

FDA Counterfeit

FDA Drug Newsletter, RSS, Podcasts

FDA Inspections References

FDA-Guidance, Compliance and Regulatory Infomation (CDER)

FDA-Warning letters

FDA: Guideline for Drug Master Files

FDA: Process Validation

Guides to Inspections

Health Canada: Good Manufacturing Practices

Health Canada: Guidance Documents

U.S. Food and Drug Administration (FDA) - Homepage

Organisations Europe (EU)

APIC 'the Active Pharmac. Ingredients Committee', division CEFIG (European Chemical Industry Council)

Drug Information Association for Europe, DIA

EDQM - European Department for the Quality of Medicines Council of Europe

ISPE - European Office

Medicines and Healthcare products Regulatory Agency (MCA) - (GB)

MEGRA e.V. (Mid-European Group of Regulatory Affairs Professionals) (german)

PDA European Office

PIC/S - Pharmaceutical Inspection Co-operation Scheme

Organisations European Countries Middle

BAH - Bundesfachverband der Arzneimittel-Hersteller e.V.

Bundesverband der Pharmazeutischen Industrie e.V. (BPI)

BV Med Bundesfachverband Medizintechnologie e.V.

DECHEMA e.V.

Deutsche Pharmazeutische Gesellschaft (DPhG)

Germany: Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik (APV)

Interpharma

Österreichische Pharmazeutische Gesellschaft

Verband der Chemischen Industrie e.V. (VCI)

Verband Forschender Arzneimittelhersteller e.V. (VFA)

Organisations European Countries South
Italy: A.F.I. Associazione Farmaceutici Industria
Organisations European Countries West
Organsisation For Professionals In Regulatory Affairs
Organisations International

ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

International Federation of Pharmaceutical Manufacturers Associations

International Pharmaceutical Federation (FIP)

Organisations USA

American Association of Pharmaceutical Scientists

American Pharmaceutical Association

Drug Information Association (DIA)

ISPE Headquaters

National Institutes of Health (NIH)

PDA Headquarters

Pharmaceutical Research and Manufacturers of America (PhRMA)

U.S. Pharmacopeia

Publisher

Beuth Verlag (DIN Standards and other national, European and international technical rules and publications)

CRC-Press (u.a. Marcel Dekker, interpharmpress)

ECV .Editio Cantor Verlag (z.B. Pharmind), german site, but some english publications

FDC Reports (z.B. The Gold Sheet) (USA)

Institute of Validation Technology (IVT)(Journal of Val. Tech. und Journal of GMP Compliance)

ISO - Intern. Organization for Standardization

Maas & Peither GMP Publishing

VDI The Association of German Engineers (VDI guidelines)

Washington Information Source (FDA documents)
Webpages - Pharma Specifications

gempex GmbH - GMP Consulting & Execution

GMP trends (USA)

Industrial Pharmacy

LabCompliance

Pharma-search-engine

Pharmaceutical online

Regulatory Affairs Professionals Society (RAPS)