International

Global Harmonization Task Force (GHTF)
http://www.ghtf.org

Good Automated Manufacturing Practice (GAMP)
http://www.ispe.org/gamp

International Conference on Harmonisation (ICH)
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

International Pharmaceutical Excipients Council (IPEC)
http://www.ipec.org

International Pharmaceutical Federation (FIP)
http://www.fip.nl/www

International Society for Pharmaceutical Engineering (ISPE)
http://www.ispe.org

Medical Device Link
http://www.devicelink.com

Parenteral Drug Association
http://www.pda.org

Pharmaceutical Inspection Cooperation Scheme (PIC/S) - GMP Guide and basic standards
http://www.picscheme.org/

Pharmaceutical Online
http://www.pharmaceuticalonline.com

The Pharmaceutical Quality Group (PQG)
http://www.pqg.org

PharmWeb
http://www.pharmweb.net

Regsource - Regulatory Information
http://www.regsource.com

Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century - Table of Contents
http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

World Health Organisation GMP Information (WHO)
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html

World Pharma Web
http://www.worldpharmaweb.com

Back to top

Asia

SFDA (PR China)
http://eng.sfda.gov.cn/cmsweb/webportal/W43879537/index.html?UID=DWV1_WOUID_URL_43879537

Health Sciences Authority (HSA) - Singapore
http://www.hsa.gov.sg

Japanese Ministry of Health, Labor and Welfare (MHW)
http://www.mhlw.go.jp/english

Malaysian National Pharmaceutical Control Board (NPCB)
http://www.bpfk.gov.my

Back to top

Australia

Australian Pesticides & Veterinary Medicines Authority (APVMA)
http://www.apvma.gov.au/

DA Information Services, Australia’s largest full service library supplier
http://www.dadirect.com

Questions & Answers on the Australian Code of GMP for medicinal products
http://www.tga.gov.au/docs/html/gmpcodqa.htm

Therapeutic Goods Administration (TGA) - Australia
http://www.tga.gov.au

Back to top

Europe

British Pharmacopoeia (BP)
http://www.pharmacopoeia.org.uk

European Chemical Industry Council - Active Pharmaceutical Ingredients Sector (CEFIC/APIC)
http://apic.cefic.org

European Commission DG Enterprise
http://ec.europa.eu/enterprise/index_en.htm

European Commission DG Enterprise - Pharmaceuticals Unit - Pharmacos
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new_en.htm

European Commission DG Enterprise - Medical Devices Sector
http://ec.europa.eu/enterprise/medical_devices/index_en.htm

European Compilation of Procedures for GMP Inspections
http://www.emea.europa.eu/Inspections/GMPCompproc.html

European Federation of Pharmaceutical Industries and Federations (EFPIA)
http://www.efpia.org

European Guide to GMP
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm

European Guide to GMP - updates etc
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/gmp_doc.htm

European Guidelines on Quality, Safety, and Efficacy for Human Use Products
http://www.emea.europa.eu/htms/human/humanguidelines/background.htm

European Guidelines on Quality, Safety, and Efficacy for Veterinary Products
http://www.emea.europa.eu/htms/vet/vetguidelines/background.htm

European Medicines Agency (EMEA)
http://www.emea.europa.eu

European Medicines Agency (EMEA) Regulatory and Procedural Guidance
http://www.emea.europa.eu/htms/human/raguidelines/intro.htm

European Medicines Agency Inspections Sector
http://www.emea.europa.eu/Inspections/index.html

European Medicines Agency Inspections - Good Manufacturing Practice
http://www.emea.europa.eu/Inspections/GMPfaq.html

European Medicines Agency Inspections - Links and Acronyms
http://www.emea.europa.eu/Inspections/Links.html

European Medicines Agency Inspections - Quality Working Party - Q&A
http://www.emea.europa.eu/Inspections/qwp/list.htm

European Pharmacopoeia (Ph Eur)
http://www.pheur.org

Irish Medicines Board (IMB)
http://www.imb.ie

Mutual Recognition Agreements (MRAs)
http://www.emea.europa.eu/Inspections/MRA.html

The Parenteral Society - UK
http://www.parenteral.org.uk

Pharmacos Enterprise DG
http://pharmacos.eudra.org

UK GMP (Orange) Guide
http://www.pharmpress.com/shop/product_display.asp?mscssid=24B9...

UK Medicines and Healthcare Products Regulatory Agency (MHRA)
http://www.mhra.gov.uk

UK Official Documents including Medicines Legislation
http://www.tso.co.uk/bookshop/bookstore.asp

Back to top

North America

Canadian HPFB Inspectorate
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/index_e.html

Food and Drug Administration (FDA)
http://www.fda.gov

FDA CBER Guidance / Guidelines / Points to Consider
http://www.fda.gov/cber/guidelines.htm

FDA GMP Regulations (CFR21)
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_01.html

FDA Human Drugs GMP notes
http://www.fda.gov/cder/dmpq/cgmpnotes.htm

FDA Inspections Operations Manual
http://www.fda.gov/ora/inspect_ref/iom/iomtc.html

FDA Inspection Guides
http://www.fda.gov/ora/inspect_ref/igs/iglist.html

FDA portal providing access to the different parts of their website
http://www.fda.gov/oc/industry/default.htm

Health Canada Compliance
http://www.hc-sc.gc.ca/dhp-mps?compli-conform/index-eng.php

Pharmaceutical and Research Manufacturers of America (PhRMA)
http://www.phrma.org

Therapeutic Products Directorate - Canada
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt

United States Pharmacopoeia (USP)
http://www.usp.org

Back to top