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UNICEF Medicines Supply Strengthening

UNICEF Medicines Supply Strengthening. WHO Technical Briefing Seminar on Essential Medicines and Health Products

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UNICEF Medicines Supply Strengthening

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  1. UNICEF Medicines Supply Strengthening WHO Technical Briefing Seminar on Essential Medicines and Health Products Tuesday 29 October 2013 Technical Specialist HenrikK.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division

  2. UNICEF • .

  3. About the Copenhagen warehouse • Entirely controlled by computer • 9300 m2 • 150m Long x 62m Wide x 24m High • 36,000 pallet locations • 8 robot cranes • Each crane operating 4 racks • Each crane operating 4500 pallets

  4. Supply in the UNICEF structure

  5. Major commodity groups • 2012: $2.468 billion in supplies and services Approximately $1.13 billion funded via Procurement Services (procurement on behalf of governments and other partners)

  6. Supplier countries

  7. Where we are • 855 staff • 135 nationalities • 163 offices • 99 countries Shanghai Dubai Panama

  8. Wheredoes UNICEF SD supply medicines • UNICEF country programmes • Procurement Services Customers UN Agencies NGO’s MOH

  9. UNICEF Quality system is based on • Division and Centre Procedures • Principles of WHO Model QA systems for Procurement, TRS 937 Annex is implemented

  10. Pre-qualification - Pharmaceuticals • Manufacturers Review of submitted documentation ( Technical Questionnaire) Export experience License to manufacture pharmaceuticals Financial status

  11. Pre-qualification - Pharmaceuticals • Pharmaceutical Product: • Two scenarios: 1. WHO Prequalified Pharmaceuticals 2. Assessed in UNICEF SD

  12. Pre-qualification - Pharmaceuticals • WHO Prequalification of suppliers of Vaccines, HIV/AIDS and malaria products • Products must be pre-qualified by WHO and listed on the website • Suppliers to confirm to UNICEF that the products are identical to those assessed by WHO

  13. Pre-qualification – Pharmaceuticals non- WHO prequalified products • Complete Interagency Pharmaceutical Product Questionnaire for manufacturers (Product Questionnaire as in Model QA system WHO TRS 937): • Full International Non-proprietary Name (INN name) • No brand or trade name • GMP certificate of FPP Manufacturing site • Marketing Authorisation in country of origin, and exporting countries if applicable • Certificate of Pharmaceutical product (CPP) • API, Reference to Pharmacopeias and CEP/DMF • GMP certificate of the API Manufacturing site/CoA of the API • Specifications for the Finished Pharmaceutical Product • (reference to Ph.Int, Ph.Eur, BP or USP where applicable) • Stability reports of the Finished Pharmaceutical Product • Language requirements: English and French unless other specified • Sample for evaluation

  14. GMP inspections – by UNICEF SD • Decision based on the regulatory environment In country of origin and prior experience of UNICEF • GMP inspection by UNICEF or a representative selected by UNICEF • Contracts Manufacture only accepted if subcontractor also is approved by UNICEF • WHO GMP guidelines used as reference • 100 GMP inspections carried out in 2007-2012. 19 companies failed • Detailed GMP inspection report forwarded to company with request to respond within 1 month

  15. GMP inspections – Continued • All manufacturers with contract are GMP inspected at regular intervals – normally every 2- 5 year • Local authority invited to participate • Joint inspections with WHO, ICRC, MSF • UNICEF is a partner to the Pharmaceutical Inspections Cooperation Scheme (PIC-S) • UNICEF use available information to waive UNICEF inspections

  16. Pre-qualification - Pharmaceuticals • Done in connection with the tender process • Supply Agreement with best offer • Practical all products are on the WHO Essential Medicines List

  17. Products received in the warehouse are - always inspected • Visual Inspection: Product Dosage form and strength Quantity CoA: satisfactory remaining shelf-life Manufactured by the approved site Random quality control in accordance with plan

  18. Quality control - testing • Analysis performed on a random basis according to an annual plan • Analysis performed by contract laboratory

  19. Quality control of direct shipment • Pre-delivery inspections • - Third party • - UNICEF Country Office • Review of packaging list and Certificate of Analysis • Random quality control testing in accordance with prior experience

  20. Local procurement • All local procurement of pharmaceuticals requires approval from UNICEF SD • Products from local manufacturers have been evaluated in countries like: • Bangladesh, India

  21. Thank you

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