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More informationAustrian Regulatory Authority
www.ages.at
CDER Freedom of Information Office Electronic Reading Room
www.fda.gov/RegulatoryInformation/foi/ElectronicReadingRoom/default.htm
Dutch Regulatory Authority
www.cbg-meb.nl
FDA
www.fda.gov
FDA The critical path to new medicinal products
www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
FDA Pharmaceutical cGMPs for the 21st century - a risk based approach
www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm
FDA Guidance Documents
www.fda.gov/RegulatoryInformation/Guidances/default
FDA Warning Letters
www.fda.gov/foi/warning
FDA Manual of Policies and Procedures (MaPPs) - CDER's official policies and procedures manual
www.fda.gov/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/default.htm
Legislation in Force
www.schengenvisainfo.com/eu-countries/
Medicines and Healthcare products Regulatory Agency (MHRA)
www.mhra.gov.uk
Medicines Evaluation Board
www.cbg-meb.nl
National Institutes of Health
www.nih.gov
US Dept Health and Human Sciences
www.dhhs.gov
Below is a link to a page on the FDA website which includes comparison charts for the FDA, EPA and OECD GLPs
If you click on the link above to open the page there will be a list of GLP sections in blue on the right (Scope, Definitions, Organization & Personnel, Facilities, Equipment, Facility Operations, Articles, Protocol & Conduct, Records & Reports, and Disqualification). Click on these sections to get to the FDA, EPA & OECD GLP Comparison Charts for these particular GLP sections.