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Useful web-sites
The following sites may be of interest to keep you updated


Biotechnology Information Portal (for Biotech firms and their suppliers):

http://www.biotechinforma.com

 

European Medicines Agency (EMEA):

http://www.EMEA.europa.eu/

 

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

 

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

 

European Guidelines on Quality, Safety, and Efficacy for Human Use Products:

http://www.emea.eu.int/htms/human/humanguidelines/background.htm

 

European Guidelines on Quality, Safety, and Efficacy for Veterinary Products:

http://www.emea.eu.int/htms/vet/vetguidelines/background.htm

 

European Pharmacopoeia (Ph Eur):

http://www.pheur.org/

 

FDA Portal providing access to the different parts of their website:

http://www.fda.gov/oc/industry/default.htm

 

FDA GMP Regulations (CFR21):

http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_01.html

 

FDA Inspections Operation 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 human drugs GMP notes:
http://www.fda.gov/cder/dmpq/cgmpnotes.htm

 

International Conference on Harmonisation (ICH):

http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

 

International Register for Certificated Auditors

http://www.irca.org/

 

International Society of Pharmaceutical Engineers (ISPE):

http://www.ispe.org/

 

Mutual Recognition Agreements (MRAs):

http://www.EMEA.eu.int/Inspections/MRA.html

 

Pharmaceutical Inspection Co-operation Scheme (PIC/S) - GMP Guide and basic standards:

http://www.picscheme.org/

 

Risk-Based Approach to cGMP for the 21st Century:

http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

 

The Pharmaceutical Quality Group (PQG):

 http://www.pqg.org/

 

The UK Medicines and Health Care Products Regulatory Agency (MHRA):

http://www.mhra.gov.uk/

 

United States Pharmacopoeia (USP):

http://www.usp.org/

 

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

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