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2 The International Pharmacopoeia + International Chemical Reference Standards - Dr Sabine Kopp – Caroline Mendy Quality Assurance and Safety: Medicines.

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Presentation on theme: "2 The International Pharmacopoeia + International Chemical Reference Standards - Dr Sabine Kopp – Caroline Mendy Quality Assurance and Safety: Medicines."— Presentation transcript:

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2 2 The International Pharmacopoeia + International Chemical Reference Standards - Dr Sabine Kopp – Caroline Mendy Quality Assurance and Safety: Medicines World Health Organization

3 3 The International Pharmacopoeia – Ph. Int. Introduction Ph. Int. - scope WHO consultative procedure What's new Link with other programmes and organisations

4 4 International Pharmacopoeia Historical overview 1874Discussion on Unification of terminology and composition of drugs 1902 First Conference organized by the Government of Belgium 1906Agreement on Unification of the Formulae of Potent Drugs ratified by 19 states 1925 Brussels agreement (signed 1929) League of Nations: international pharmacopoeia

5 5 International Pharmacopoeia Historical overview First meeting (experts from B, CH, DK, F, NL, UK, USA) - League of Nations 1947 Interim Commission of WHO takes up health related work of League of Nations 1948 First World Health Assembly established Expert Committee on Unification of Pharmacopoeia

6 6 International Pharmacopoeia Historical overview WHA approved publication of Pharmacopoeia Internationalis WHO Expert Committee: 1951 named: Expert Committee on International Pharmacopoeia 1959 named: Expert Committee on Specifications for Pharmaceutical Preparations --> to date

7 7 International Pharmacopoeia A collection of monographs and requirements for: Drug substances Excipients Finished dosage forms General methods and requirements: dosage forms, e.g. tablets, liquid preparation for oral use dissolution testing Supplementary information, e.g. General Guidelines for Chemical Reference Substances Infrared reference spectra

8 8 International Pharmacopoeia Scope since 1975 Model List of Essential Medicines and Medicines recommended and specifications needed by WHO Programmes, e.g. to treat Malaria, TB, HIV/AIDS and for children! implementation: ready for use by Member States

9 9 WHO Procedure for the preparation of drug Quality Control specifications (1) …..or why it takes so long…. Step 1: Identification of specific pharmaceutical products for which Quality Control (QC) specifications need to be developed, confirmation by all WHO parties concerned (Expert Committee, Specific disease programme, pre-qualification project team, etc.) Step 2: Provision of contact details from manufacturers of the above products in collaboration with all parties concerned Step 3: Contact manufacturers for provision of QC specifications and samples Step 4: Identify and contact QC laboratories for collaboration in the project (2-3 laboratories depending on how many pharmaceutical products have been identified in step 1), Contract for laboratory work

10 10 WHO Procedure for the preparation of drug Quality Control specifications (1) …..or why it takes so long…. Step 5: Prepare the contract for drafting the specifications and undertaking the necessary laboratory work Step 6: Search for information on QC specifications available in the public domain Step 7: Laboratory testing, development and validation of Quality Control Specifications Step 8: Support WHO Collaborating Centre in the establishment of International Chemical Reference Substances Step 9: Follow the consultative process, mailing of draft specifications to Expert Panel and specialists

11 11 WHO Procedure for the preparation of drug Quality Control specifications (2) …..or why it takes so long…. Step 10: Discussion of comments with contract laboratories, WHO Collaborating Centres, additional laboratory testing to verify and/or validate specifications Step 11: Consultation to discuss the comments and test results received as feed-back Step 12: recirculation for comments Step 13: as step 10 Step 14: Present the drafts to the WHO Expert Committee on Specifications for Pharmaceutical Preparations for possible formal adoption, …if not adopted repetition of steps 11 to 13 as often as necessary

12 12 WHO does the work … with Partners National and regional authorities International organizations (UNAIDS, UNICEF, World Bank, etc.) International professional and other associations, NGOs (including consumer associations, MSF, industry: IFPMA-IGPA-WSMI, FIP, WMA, etc.) WHO Expert Panel on The International Pharmacopoeia and Pharmaceutical Preparations (official nomination process) Specialists from all areas, regulatory, university, industry WHO Collaborating Centres (official nomination process) Pharmacopoeia Commissions and Secretariats, national institutions and institutes Regional and interregional regulatory groups (ASEAN, ICH, etc)

13 13

14 14 International Pharmacopoeia current: 4th Edition + 1st Supplement Consolidated in : 2 Volumes - Vol. 1: pharmaceutical substances (A-O) - Vol. 2: pharmaceutical substances (P-X) + dosage forms + radiopharmaceuticals + methods of analysis + reagents 1st Supplement - new requirements and revisions Available in Publication, CD-ROM and Online

15 15 4 th Edition – new (1) 4 th Edition Monographs on antiretrovials (ARVs) Revision of existing monographs Improved presentation Improved cross-referencing to general methods Improved search functions for CD-ROM and online version New notice on "manufacture" New notice on impurities New list of impurities shown to be controlled by tests

16 16 4 th Edition – new (2) First Supplement New monographs for ARVs, TB and Malaria medicines, medicines for children Revisions, 125 IR reference spectra, supplementary info

17 17 New Ph. Int. monographs - adopted by 42 nd WHO Expert Committee –Lumefantrine –Artemether and lumefantrine tablets –Rifampicin, isoniazid and ethambutol tablets –Rifampicin and isoniazid dispersible tablets –Rifampicin, isoniazid and pyrazinamide dispersible tablets –Zinc sulfate –Zinc sulfate tablets, paediatric –Zinc sulfate oral solution, paediatric –Magnesium sulfate injection

18 18 New Ph. Int. monographs - adopted by 43rd WHO Expert Committee –Efavirenz capsules –Efavirenz oral solution –Emtricitabine –Nevirapine –Nevirapine oral suspension –Nevirapine tablets –Zidovudine, Lamivudine and Nevirapine tablets

19 19 New Ph. Int. monographs - adopted by 43rd WHO Expert Committee –Artemether and Lumefantrine oral suspension –Chloroquine sulfate oral solution –Quinine sulfate tablets –Cycloserine –Cycloserine capsules –Ethambutol hydrochloride tablet –Mebendazole –Oseltamivir phosphate –Chewable Mebendazole tablets

20 20 New Ph. Int. monographs - adopted by 43rd WHO Expert Committee The following monographs adopted subject to minor modifications: Fludeoxyglucose (18F) injection Gallium citrate (67Ga) injection Technetium (99mTc) pentetate complex injection Sodium pertechnetate (99mTc) injection (fission) The following monographs adopted subject to minor modifications and final confirmation by IAEA: Iobenguane (123I) injection Sodium iodide (131I) injection Sodium iodide (131I) solution Sodium pertechnetate (99mTc) injection (non-fission) Thallous chloride (201Tl) injection

21 21 New Ph. Int. Work Programme – adopted by WHO Expert Committee Medicines for HIV/AIDS-related conditions –Antibacterials –Antifungal, antiprotozoal and antimycobacterial agents Anti-epilectics –paediatric formulations (oral liquids and chewable tablets) Anthelmintics Palliative care Reproductive health Insulins Large volume parenterals (eg glucose IV infusion)

22 22 International Chemical Reference Substances (ICRS) 207 ICRS + 12 melting point reference substances Established by WHO COLLABORATING CENTRE FOR CHEMICAL REFERENCE SUBSTANCES in Sweden Primary reference standard Linked to Ph.Int. Price for ICRS US$ 70 Includes: - Directions for use - Certificate of analysis Monitoring and on-going stability testing Can be used for tests and analysis not included in Ph.Int.

23 23 International Infrared Reference Spectra Established by WHO COLLABORATING CENTRE FOR CHEMICAL REFERENCE SUBSTANCES in Sweden 155 International Infrared Reference Spectra (125 published in Ph.Int. 4 th Ed. Suppl. 1) IR-spectrum of lamivudine

24 24 Int. Ph. and links with other programmes and organizations Collaboration with national and regional pharmacopoeias, incl. Brazilian Pharmacopoeia, Chinese Pharmacopoeia, JP, IP, Ph.Eur., USP, and PDG Collaboration with national/regional regulatory authorities and quality control laboratories Collaboration with international organizations (e.g. UNICEF, IAEA) Links with Prequalification Programme - A United Nations Programme managed by WHO Collaboration with manufacturers worldwide

25 25 Int. Ph. and links with other programmes and organizations Monographs for antimalarials, anti-TB drugs, etc. (different clusters in WHO) General requirements for products derived from plant materials (WHO Traditional Medicines Programme) Monographs for radiopharmaceuticals (with International Atomic Energy Agency - IAEA) Monographs for excipients (with Pharmacopoeial Discussion Group – PDG, IPEC)

26 26 UN Prequalification of Medicines Programme International Pharmacopoeia (Ph.Int.) and its international chemical reference standards (ICRS) are essential tool for PQ activities The Ph.Int. enjoys priority in the PQ Programme BP, Ph.Eur. and USP methods should only be applied, where an Applicant has made specific commitments to do so in the dossier

27 27 UN Prequalification of Medicines Programme The International Pharmacopoeia is the only reference source for many of the priority medicines dealing in the PQ programme, such as: artemisinin-related Antimalarial products (e.g. artemether, artesunate, artenimol); Antiretrovirals products (e.g. abacavir, efavirenz, nelfinavir mesilate, ritonavir); Fixed-dose combinations (e.g. artemether/lumefantrine tablets, lamivudine/nevirapine/zidovudine tablets); Paediatric formulations (e.g. artemether and lumefantrine oral suspension, paediatric didanosine liquid for oral use)

28 28 The International Pharmacopoeia's advantages (1) 1. Specifications validated internationally, through an independent scientific process 2. Input from WHO Collaborating Centres, national Drug Quality Control laboratories 3. Collaboration with manufacturers around the world, especially for new projects 4. Development considering the costs of analysis, i.e. using as few ICRS as possible

29 29 The International Pharmacopoeia's advantages (2) 5. Collaboration with standard-setting organizations and parties, including regional and national pharmacopoeias 6. Networking and close collaboration with WHO Member States, Drug Regulatory Authorities 7. Links with other WHO activities 8. FREE FOR USE by all Member States

30 30 Further questions ??????

31 31 Safe quality medicines


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