GMP MANUALGood Manufacturing Practice & Implementation
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Knowledge is Power.With the GMP MANUAL, you have
the information you need to make sure yourGMP program in the best it can be.
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Bestpractices
Industryperspectives
How-to-do
Bench-marks
Checklists
Examples
ICH
WHO
US-FDA
Japan
PIC/S
EU
GMPin Practice
GMPRegulations
This is a great manual.
I wish we had access
to this many years
ago.
My favorite chapters
were documentation,
research and develop-
ment (great informa-
tion about GLP vs.
GMP vs. GCP), risk
management.
I could replace over
10 training books
that I have in my office
with just this one
document.
Customer ”
“
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GeneralChapters
TechnologyChapters
ValidationChapters
ManufacturingChapters
SpecialChapters
GMP inPractice
GMPRegulations
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Valuable reasons to buy the GMP MANUAL
1 Benchmark your proceduresIt´s important to know how other experts solved the qualitychallenge in their company. With that knowledge you can impro-ve and fine-tune your procedures and processes.
2 Regulations and interpretations in one convenient sourceYou need complete GMP information in one easy location. Areyou wasting time looking at several websites to gather the infor-mation you need? We do that for you and cover regulations andthe interpretations all at one source, with one search engine tosave you time & money.
3 The only current GMP knowledge sourceAs you know, only the most current information is good informa-tion. We update the GMP MANUAL on a regular basis. Our know-ledge source remains up-to-date.
4 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 GMP MANUAL isused in more than 65 countries around the globe. More than10,000 users must be right. They all save time & money by usingthe GMP MANUAL knowledge source.
5 Training MaterialIf you have to prepare presentations and training programs, doyou need training/reference material for new employees? TheGMP MANUAL’s 21 chapters cover nearly every topic in the areaof GMP. Clear description – easy to understand – a must have foryour business.
6 Global perspective of GMPYou get information from the most important GMP regions:Europe, USA, Japan. We deliver information about globallyimplemented GMP procedures that will fulfil all requirements.Be sure to follow the best practices outlined in the GMP MANUAL.
7 It’s easy to find the appropriate information when neededYou will find it an easy and efficient way to retrieve the appro-priate information 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 …
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GeneralChapters
TechnologyChapters
ValidationChapters
ManufacturingChapters
SpecialChapters
GMP inPractice
GMPRegulations
Quality ManagementPersonnelRisk ManagementQuality ControlDocumentationInspections
FacilitiesEquipmentPremisesPharmaceutical Water
QualificationProcess ValidationCleaning ValidationComputer Validation
ProductionSterile ManufacturingPackaging
R & DContractingQuality ToolsAPI
US-FDA
Europe
Japan
ICH
PIC/S
WHO
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…The GMP MANUAL
occupies a spot in my
bookcase and I often
have the occasion to
refer to it. If you are
a professional in the
field of GMP and regu-
latory compliance, you
may find it should be in
your bookcase too.
Bob DanaSenior Vice President,Regulatory Affairs andPDA Training and ResearchInstitute
Supported by experts andAdvisory Board membersfrom Europe, United Statesof America and Japan.
Recommended by ParenteralDrug Association (PDA) andRegulatory AffairsProfessionals Society (RAPS).
”
“
www.gmp-manual.com8
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GMP MANUAL OnlineWith nothing more than an internet connection, you can access the ONLINEversion of the GMP MANUAL. Using either a corporate or a named-user license,you always have access to the current GMP MANUAL 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
� Includes checklists, templates and examples of SOPs
� Automatically updated
� No shipping costs
GMP MANUAL 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
GMP MANUAL Paper and CD-ROMThe paper version of the GMP MANUAL 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.
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Table of Contents
GMP 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
GMP Regulations:Continuously updated
A. Index
B. Japan
C. EU
D. USA
E. ICH
F. PIC/S
G. WHO
H. Other Organizations
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Important GMP Links
EuropeEU-GMP-Guidelineshttp://ec.europa.eu/enterprise/pharmaceuticals/eudEuropean Commission Enterprise DG Pharmaceuticalshttp://ec.europa.eu/enterprise/pharmaceuticals/indEMEA NEWSwww.emea.europa.eu/whatsnewp.htm
USAU.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.htm
OthersICHwww.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.org
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