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The International Pharmacopoeia + International Chemical Reference Standards - Dr Sabine Kopp – Caroline Mendy Quality A

The International Pharmacopoeia + International Chemical Reference Standards - Dr Sabine Kopp – Caroline Mendy Quality Assurance and Safety: Medicines World Health Organization . The International Pharmacopoeia –Ph. Int. . Introduction Ph. Int. - scope WHO consultative procedure What's new

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The International Pharmacopoeia + International Chemical Reference Standards - Dr Sabine Kopp – Caroline Mendy Quality A

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

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

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

  4. International PharmacopoeiaHistorical overview - 2 - • 1937 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

  5. International PharmacopoeiaHistorical overview - 3 - • 1950 WHA approved publication of Pharmacopoeia Internationalis WHO Expert Committee: • 1951named: Expert Committee on International Pharmacopoeia • 1959named: Expert Committee on Specifications for Pharmaceutical Preparations --> to date

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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 • http://www.who.int/medicines/publications/pharmacopoeia/overview/

  13. 4th Edition – new (1) 4th 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

  14. 4th Edition – new (2) First Supplement • New monographs for ARVs, TB and Malaria medicines, medicines for children • Revisions, 125 IR reference spectra, supplementary info

  15. New Ph. Int. monographs - adopted by 42nd 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

  16. 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

  17. 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

  18. 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

  19. 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)

  20. 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.

  21. 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. 4th Ed. Suppl. 1) IR-spectrum of lamivudine

  22. 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

  23. 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)

  24. 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

  25. 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-relatedAntimalarial 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)

  26. 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

  27. 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

  28. Further questions ?????? http:www.who.int/medicines

  29. Safe quality medicines

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