EDQMPublications
EDQMPublications
Mrs Caroline Larsen Le TarnecHead Public Relations & Documentation Division
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 1
The EuropeanPharmacopoeiaThe EuropeanPharmacopoeia
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved
SIXTH EDITION: 3 Suppl/yearPublication status: Last supplement 6.8 released in December 09Implemented in July 2010Non-cumulativeChange bars indicate changes to previous version.
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IntroductionIntroduction
GeneralNoticesGeneralGeneralNoticesNotices
GeneralTextsGeneralGeneralTextsTexts
GeneralMonographsGeneralMonographs
General organisation: volume 1General organisation: volume 1
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved
Dosage formsDosage forms
VaccinesVaccines
ImmunoseraImmunosera
Radiopharm.Radiopharm.
SuturesSutures
HomoeopathyHomoeopathy
GeneralNoticesGeneralNotices
GeneralTextsGeneralTexts
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General organisation: volume 2General organisation: volume 2
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved
Other specificmonographs
Other specificmonographs
IndexIndex
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C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved
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6th Edition Supplement
Publication Schedule
Implementation Date
6.0 01/06/2007 01/01/20086.1 01/10/2007 01/04/20086.2 01/01/2008 01/07/20086.3 01/06/2008 01/01/20096.4 (+reagents) 01/10/2008 01/04/20096.5 01/01/2009 01/07/20096.6 01/06/2009 01/01/20106.7 (+reagents) 01/10/2009 01/04/20106.8 01/01/2010 01/07/20107.0 01/06/2010 01/01/2011
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European PharmacopoeiaEuropean Pharmacopoeia• Electronic versions
– ~ same price, same publication programme – cumulative– available for standalone computers (since 6.6 on DVD) – since supplement 6.6: a new publication software (with
functionality of the online version) is also on the DVD (7th edition: only new software will be available!)
– available online (internet)– new: monthly updated Spanish version (~200 texts/month)– new: archive version for current subscribers – licence model:
• 1 licence = 1 simultaneous user, maximum 2 computers
H-J. Bigalke, 08/12/09 ©2009 EDQM, Council of Europe, All rights reserved
Archive VersionArchive Version
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 8
Spanish VersionSpanish Version
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 9
The European Pharmacopoeia 7th
EditionThe European Pharmacopoeia 7th
Edition
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved
SEVENTH EDITION: 3 Suppl/yearPublication (about): July, September, DecemberImplemented in July, January, AprilNon-cumulativeChange bars indicate changes to previous version.
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What has changed since the 6th Ed.?What has changed since the 6th Ed.?A short selection of the most interesting topics:• New Chapter 5.15: Functionality-related
characteristics of excipients;• Revision of the chapters:2.8.3 Pesticide residues
2.6.12 : Microbiological examination of non-sterile products: microbial enumeration tests
2.6.13 : Microbiological examination of non-sterile products: test for specified micro-organisms
• . C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 18
What has changed since the 6th Ed?What has changed since the 6th Ed?2.2.46 : Chromatographic separation techniques 2.8.22 : Determination of ochratoxin A in herbal drugs5.1.4 : Microbiological quality of non-sterile
pharmaceutical preparation and substances for pharmaceutical use
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What has changed since the 6th Ed?What has changed since the 6th Ed?
NEW Indication of the status of pharmacopoeial harmonization between EP, USP and JP
In a chapter 5.8 : Pharmacopoeial harmonization of the following chapters Electrophoresis (2.2.31); Capillary electrophoresis (2.2.47); Isoelectric focusing (2.2.54); Peptide mapping (2.2.55); Amino acid analysis (2.2.56); Friability of uncoated tablets (2.9.7); Specific surface area by gas adsorption (2.9.26); Powder flow (2.9.36); Optical microscopy (2.9.37); Particle-size distribution estimation by analytical sieving (2.9.38)
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 20
What has changed since the 6th Ed?What has changed since the 6th Ed?
• New important monographs:Valsartan; Ziprasidone hydrochloride monohydrate;
Teicoplanin; Telmisartan; Tiotropium bromide; Saquinavir mesilate; Sevoflurane; Pantoprazole sod. Sesquihydrate; Pramipexole dihydrochloride monohydrate; Raloxifene hydrochloride; Levetiracetam; Meropenem; Irbesartan; Fluvastatin sodium ; Adapalene; Docetaxel trihydrate; Entacapone; Epinastine hydrochloride
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 21
PharmeuropaPharmeuropa
• Published quarterly• A NEW EDITORIAL
LINE• Draft monographs
for comment• News and general
information• Readers’ tribune
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved22
Pharmeuropa Bio & Scientific NotesPharmeuropa Bio & Scientific Notes
• Results of collaborative trials on the establishment of biological reference substances
• Scientific articles related to the European Pharmacopoeia
• Searchable on scientific search engines (PubMed in NLM)
• Published twice a year
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 23
Standard TermsStandard Terms
A glossary in 31 languages of: • pharmaceutical
dosage forms• routes of
administration• containers
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Standard TermsStandard Terms
Very useful for: • MA dossiers• Leaflets• Labels
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 31
Standard Terms OnlineStandard Terms Online
• Address: http://http://www.edqm.euwww.edqm.eu//StandardTermsStandardTerms//
• Based on Unicode character encoding, available only on the most recentcomputer operating systems
• No printed version available any more
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 32
Blood componentsBlood components
• 14th Edition (2008) Guidelines and principlesfor the preparation, use and quality assurance ofblood components
• Contains measuresdesigned to ensure thesafety, efficacy andquality of bloodcomponents
• Particularly intended for all those working in bloodtransfusion services
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 34
Organ transplantationOrgan transplantation• Guide to safety and quality assurance for the
transplantation of organs, tissues and cells - 3rd edition(2007)
• Currently published by the Council of Europe, in the future to bepublished by the EDQM
• Guidance to maximise the quality of organs, tissues and cells, and thereby the success rate of transplants, and to minimise risks
• Includes safety and quality assurance standards for theprocurement, preservation, processing and distribution oforgans, tissues and cells of human origin (allogenic andautologous) used for transplantation purposes
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 35
NEW Pharmaceutical Care:NEW Pharmaceutical Care:
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved
• report on the current awareness and understanding of pharmaceutical care• approaches for quality assessment• implementation of pharmaceutical care in practice• required competences and skills• conclusions of 58 replies from 17 countries
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Technical guidesTechnical guides• Technical guides for:
– the elaboration of monographs– the elaboration of monographs on synthetic peptides and
recombinant DNA proteins– structure & nomenclature of chemical formulae– herbal drugs and herbal drug preparations– fatty oils and derivatives– vaccines and other immunological human medicinal products
• European Pharmacopoeia Style Guide• Free to download: www.edqm.eu Products & Services
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 37
Combistats™Combistats™
• A statistical software specifically designed to use together with general chapter 5.3 Statistical analysis of results
• Published directly by the EDQM
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 38
Combistats™Combistats™• For more information about the software
please contact:[email protected]
• Website:http://combistats.edqm.eu/where a free demo version can be downloaded
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 40
Checking the authenticityChecking the authenticity• Users of the Pharmacopoeia are advised to
register their copy, using our website:–– https://https://www.edqm.euwww.edqm.eu/register/register
• Register with the unique ID (EPID) number shown on the label
• This registration is required for– Users of the electronic versions (password/activation)– Accessing our helpdesk
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 41
Checking the authenticity -the hologram -
Checking the authenticity -the hologram -
1. Colourful areas
2. Mirrored minitext
3. Colourful letters/stars
4. Lens effect
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• Q: I am only interested in one monograph. Can I just get a copy of that?
• A: No• Why? The specific monographs contain
a number of cross references to other parts of the publication (general monographs, general methods…), so a monograph is never self-sufficient.
C. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved
FAQ on publicationsFAQ on publications
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Questions?Questions?
• EDQM Helpdesk: www.edqm.eu/hd• Select the right thematic and ask your
question• 90 EDQM staff in back office to answer all
questions received• The only channel to use to contact EDQM for
technical, scientific and commercial mattersC. Larsen Le Tarnec, 29/01/10©2010 EDQM, Council of Europe, All rights reserved 44
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Distributors in India (2)Distributors in India (2)• M/s SHAH BOOK HOUSE PVT
LTDDevka Mahal, Opp CentralBank, Bank StreetKoti, 500095 HYDERABAD
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