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UNICEF Medicines Supply Strengthening

UNICEF Medicines Supply Strengthening. WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Tuesday 30 October 2012 Technical Specialist Henrik K.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division. UNICEF. About the Copenhagen warehouse.

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UNICEF Medicines Supply Strengthening

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  1. UNICEF Medicines Supply Strengthening WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Tuesday 30 October 2012 Technical Specialist Henrik K.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division

  2. UNICEF • .

  3. About the Copenhagen warehouse Over 20,000 m2, 36,000 pallets Fully automated

  4. Major commodity groups 2011 (millions of US$)

  5. Supplies then and now

  6. Where UNICEF supplies are used by value/percentage

  7. Top supplier countries 2011 (millions of US$)

  8. Where we are Supply Division: Copenhagen, New York Supply hubs: Panama, Dubai, Shanghai Field warehouses by value of inventory, in US$’

  9. Where does UNICEF SD supply medicines • UNICEF country programmes • Procurement Services Customers UN Agencies NGO’s MOH

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

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

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

  13. 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

  14. Pre-qualification – Pharmaceuticalsfor none WHO prequalified products • Complete Interagency Pharmaceutical Product Questionnaire for manufacturers (Product Questionnaire as in Model QA system WHO TS 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

  15. GMP inspections by UNICEF SD • Principles of Quality System for GMP inspections in accordance with PIC-s Quality System requirement for GMP inspectorates is followed. WHO GMP Guidelines used as reference • 100 GMP inspections carried out 2007-2012. 19 Companies failed • Detailed GMP inspection report forwarded to the company with request to respond within 1 month. • All manufacturers with contract are GMP inspected at regular interval – normally every 2-5 years

  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 www.unicef.org/supply Thank you www.unicef.org/supply hnielsen@unicef.org

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