1 / 21

UNICEF Medicines Supply Strengthening

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

yered
Download Presentation

UNICEF Medicines Supply Strengthening

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related