GMP MANUAL - GMP Publishing

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Table of ContentsGMP in Practice:Written by internationally renowned industryexperts.1. Quality Management2. Personnel3. Premises4. Facilities and Equipment5. Pharmaceutical Water6. Qualification7. Process Validation8. Cleaning Validation9. Computer Validation10. Risk Management11. Production12. Sterile Manufacturing13. Packaging14. Laboratory and Analytical Controls15. Documentation16. Research and Development17. Contract Manufacturing and Analysis18. Inspections19. Quality Unit20. Quality Tools21. Active Pharmaceutical IngredientsGMP Regulations:Continuously updatedA. IndexB. JapanC. EUD. USAE. ICHF. PIC/SG. WHOH. Other Organizations10www.gmp-manual.com
Important GMP LinksEuropeEU-GMP-Guidelineshttp://ec.europa.eu/enterprise/pharmaceuticals/eudEuropean Commission Enterprise DG Pharmaceuticalshttp://ec.europa.eu/enterprise/pharmaceuticals/indEMEA NEWSwww.emea.europa.eu/whatsnewp.htmUSAU.S. Food and Drug Administration (FDA) Homewww.fda.gov21 CFRwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfmFDA: Drug Newsletter, RSS, Podcastswww.fda.gov/Drugs/ucm136245.htmFDA Guidelines (CDER)www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htmFDA: Warning letterswww.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htmFDA: Guides to Inspectionswww.fda.gov/ICECI/Inspections/InspectionGuides/default.htmOthersICHwww.ich.orgPIC/Swww.picscheme.orgWHOhttp://www.who.int/medicines/publications/en/AssociationsPDA – Parenteral Drug Associationwww.pda.orgRAPS – Regulatory Affairs Professionals Societywww.raps.orgISPE – International Society of Pharmaceutical Engineerswww.ispe.orgDIA – Drug Information Associationwww.diahome.orgMore Links: www.gmp-publishing.com11www.gmp-manual.com
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