GMP MANUAL - GMP Publishing
GMP MANUAL - GMP Publishing
GMP MANUAL - GMP Publishing
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<strong>GMP</strong> <strong>MANUAL</strong>Good Manufacturing Practice&ImplementationKnowledge is Power.With the <strong>GMP</strong> <strong>MANUAL</strong>, you havethe information you need to make sure your<strong>GMP</strong> program in the best it can be.www.gmp-manual.com
BestpracticesBenchmarksIndustryperspectives<strong>GMP</strong>in PracticeChecklistsHow-to-doExamplesICHJapanWHO<strong>GMP</strong>RegulationsPIC/SUS-FDAEU2www.gmp-manual.com
“This is a great manual.I wish we had accessto this many yearsago.My favorite chapterswere documentation,research and development(great informationabout GLP vs.<strong>GMP</strong> vs. GCP), riskmanagement.I could replace over10 training booksthat I have in my officewith just this onedocument.Customer”3www.gmp-manual.com
GeneralChaptersTechnologyChapters<strong>GMP</strong> inPracticeValidationChaptersManufacturingChaptersSpecialChapters<strong>GMP</strong>Regulations4www.gmp-manual.com
Valuable reasons to buy the <strong>GMP</strong> <strong>MANUAL</strong>1234567Benchmark your proceduresIt´s important to know how other experts solved the qualitychallenge in their company. With that knowledge you can improveand fine-tune your procedures and processes.Regulations and interpretations in one convenient sourceYou need complete <strong>GMP</strong> information in one easy location. Areyou wasting time looking at several websites to gather the informationyou need? We do that for you and cover regulations andthe interpretations all at one source, with one search engine tosave you time & money.The only current <strong>GMP</strong> knowledge sourceAs you know, only the most current information is good information.We update the <strong>GMP</strong> <strong>MANUAL</strong> on a regular basis. Our knowledgesource remains up-to-date.More than 10,000 satisfied professionals around the globeWe realize that you are looking for a knowledge source that isaccepted by the industry and regulators. The <strong>GMP</strong> <strong>MANUAL</strong> isused in more than 65 countries around the globe. More than10,000 users must be right. They all save time & money by usingthe <strong>GMP</strong> <strong>MANUAL</strong> knowledge source.Training MaterialIf you have to prepare presentations and training programs, doyou need training/reference material for new employees? The<strong>GMP</strong> <strong>MANUAL</strong>’s 21 chapters cover nearly every topic in the areaof <strong>GMP</strong>. Clear description – easy to understand – a must have foryour business.Global perspective of <strong>GMP</strong>You get information from the most important <strong>GMP</strong> regions:Europe, USA, Japan. We deliver information about globallyimplemented <strong>GMP</strong> procedures that will fulfil all requirements.Be sure to follow the best practices outlined in the <strong>GMP</strong> <strong>MANUAL</strong>.It’s easy to find the appropriate information when neededYou will find it an easy and efficient way to retrieve the appropriateinformation needed. We implemented a powerful searchengine, a comprehensive index and one table of contents. Don’tspend time searching – find what you need quickly!and there are more …5www.gmp-manual.com
GeneralChaptersQuality ManagementPersonnelRisk ManagementQuality ControlDocumentationInspectionsTechnologyChaptersFacilitiesEquipmentPremisesPharmaceutical Water<strong>GMP</strong> inPracticeValidationChaptersQualificationProcess ValidationCleaning ValidationComputer ValidationManufacturingChaptersProductionSterile ManufacturingPackagingSpecialChaptersR & DContractingQuality ToolsAPI<strong>GMP</strong>RegulationsUS-FDAEuropeJapanICHPIC/SWHO6www.gmp-manual.com
Supported by experts andAdvisory Board membersfrom Europe, United Statesof America and Japan.Recommended by ParenteralDrug Association (PDA) andRegulatory AffairsProfessionals Society (RAPS).“…The <strong>GMP</strong> <strong>MANUAL</strong>occupies a spot in mybookcase and I oftenhave the occasion torefer to it. If you area professional in thefield of <strong>GMP</strong> and regulatorycompliance, youmay find it should be inyour bookcase too.”Bob DanaSenior Vice President,Regulatory Affairs andPDA Training and ResearchInstitute7www.gmp-manual.com
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<strong>GMP</strong> <strong>MANUAL</strong> OnlineWith nothing more than an internet connection, you can access the ONLINEversion of the <strong>GMP</strong> <strong>MANUAL</strong>. Using either a corporate or a named-user license,you always have access to the current <strong>GMP</strong> <strong>MANUAL</strong> information.General information and functionalities:● Easy and direct access via your Internet browser● More content than the paper version● Comfortable and full text search● Copy and paste● Set-up bookmarks● Print● Includes checklists, templates and examples of SOPs● Automatically updated● No shipping costs<strong>GMP</strong> <strong>MANUAL</strong> CD-ROMThe CD-ROM version works with every computer and is perfect when you arein the field or traveling. It is small enough to come along wherever you go.Other great features:● Easy to use● Full text search● Copy and paste● Set up bookmarks● Print<strong>GMP</strong> <strong>MANUAL</strong> Paper and CD-ROMThe paper version of the <strong>GMP</strong> <strong>MANUAL</strong> is a convenient way to read entirechapters or to view multiple sections at once. Our five loose-leaf binders area must for every pharmaceutical company library.The CD-ROM comes along with the paper version to complement yourcollection. It contains the same information as found in the binders andenables a comfortable text search.9www.gmp-manual.com
Table of Contents<strong>GMP</strong> 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 Ingredients<strong>GMP</strong> Regulations:Continuously updatedA. IndexB. JapanC. EUD. USAE. ICHF. PIC/SG. WHOH. Other Organizations10www.gmp-manual.com
Important <strong>GMP</strong> LinksEuropeEU-<strong>GMP</strong>-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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