EDQM Publications. Mrs Caroline Larsen Le Tarnec Head Public Relations & Documentation Division

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2 The EuropeanPharmacopoeia SIXTH EDITION: 3 Suppl/year Publication status: Last supplement 6.8 released in December 09 Implemented in July 2010 Non-cumulative Change bars indicate changes to previous version. C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 2

3 General organisation: volume 1 Introduction General Notices General Texts General Monographs Dosage forms Vaccines Immunosera Radiopharm. Sutures Homoeopathy C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 3

5 6th Edition Supplement Publication Schedule Implementation Date /06/ /01/ /10/ /04/ /01/ /07/ /06/ /01/ (+reagents) 01/10/ /04/ /01/ /07/ /06/ /01/ (+reagents) 01/10/ /04/ /01/ /07/ /06/ /01/2011 C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 5

European Pharmacopoeia Electronic versions ~ same price, same publication programme cumulative available for standalone computers (since 6.6 on DVD) since supplement 6.

6 European 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 (7 th 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/ EDQM, Council of Europe, All rights reserved

C. Larsen Le Tarnec, 29/01/10 2010 EDQM,

17 The European Pharmacopoeia 7 th Edition SEVENTH EDITION: 3 Suppl/year Publication (about): July, September, December Implemented in July, January, April Non-cumulative Change bars indicate changes to previous version. C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 17

18 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: Pesticide residues : Microbiological examination of non-sterile products: microbial enumeration tests : Microbiological examination of non-sterile products: test for specified micro-organisms C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 18.

19 What has changed since the 6th Ed? : Chromatographic separation techniques : Determination of ochratoxin A in herbal drugs : Microbiological quality of non-sterile pharmaceutical preparation and substances for pharmaceutical use C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 19

20 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/ EDQM, Council of Europe, All rights reserved 20

21 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/ EDQM, Council of Europe, All rights reserved 21

22 Pharmeuropa Published quarterly A NEW EDITORIAL LINE Draft monographs for comment News and general information Readers tribune C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 22

Pharmeuropa Bio & Scientific Notes Results of collaborative trials on the establishment of biological reference substances Scientific articles related to the European

23 Pharmeuropa 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/ EDQM, Council of Europe, All rights reserved 23

Standard Terms Very useful for: MA dossiers Leaflets Labels C.

32 Standard Terms Online Address: Based on Unicode character encoding, available only on the most recent computer operating systems No printed version available any more C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 32

Blood components 14th Edition (2008) Guidelines and principles for the preparation, use and quality assurance of blood components Contains measures designed to ensure the safety, efficacy

34 Blood components 14th Edition (2008) Guidelines and principles for the preparation, use and quality assurance of blood components Contains measures designed to ensure the safety, efficacy and quality of blood components Particularly intended for all those working in blood transfusion services C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 34

35 Organ 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 be published 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 the procurement, preservation, processing and distribution of organs, tissues and cells of human origin (allogenic and autologous) used for transplantation purposes C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 35

NEW Pharmaceutical Care: report on the current awareness and understanding of pharmaceutical care approaches for quality assessment implementation of pharmaceutical care

36 NEW Pharmaceutical Care: 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 C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 36

37 Technical 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: Products & Services C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 37

38 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/ EDQM, Council of Europe, All rights reserved 38

41 Checking the authenticity Users of the Pharmacopoeia are advised to register their copy, using our website: 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/ EDQM, Council of Europe, All rights reserved 41

42 Checking the authenticity - 1. Colourful areas 2. Mirrored minitext 3. Colourful letters/stars 4. Lens effect the hologram - C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 42

43 Q: I am only interested in one monograph. Can I just get a copy of that? A: No FAQ on publications 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/ EDQM, Council of Europe, All rights reserved 43

44 Questions? EDQM Helpdesk: 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 matters C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 44

45 Distributors in India (1) UNITED BOOKS AND PERIODICALS 7, Vishwadham, Prabhat Clny. Rd. n 9 Santacruz (East) MUMBAI TEL: or FAX: CONTACT: Rahul M. Gavankar, unitedbooks@mtnl.net.in or unitedbooks@gmail.com EDUCATIONAL BOOK CENTRE 33, Bhagwan Bhuvan, 196 Samuel Street MUMBAI TEL: ; FAX: CONTACT: Mukesh H. Doshi, ebc@vsnl.net C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 45

46 Distributors in India (2) M/s SHAH BOOK HOUSE PVT LTD Devka Mahal, Opp Central Bank, Bank Street Koti, HYDERABAD TEL: ; FAX: CONTACT: Anil Shah, KAMAL UDYOG F-4, 1st Floor, Velho Trade Centre Gen. B. Guesdes Road, Next to Goa Sahakar Bhandar Panaji, GOA TEL: ; FAX: C. Larsen Le Tarnec, 29/01/ EDQM, Council of Europe, All rights reserved 46

The International Pharmacopoeia Overview

The International Pharmacopoeia Overview Prepared by Caroline Mendy Technical Officer - Quality Assurance and Safety: Medicines The International Pharmacopoeia P Content & Scope WHO Expert Committee on