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Medicine Supply Systems Strengthening Access to Medicines .

Medicine Supply Systems Strengthening Access to Medicines . Henrik K.Nielsen Technical Specialist Essential Medicines Unit - Medicines and Nutrition Centre UNICEF Supply Division, Copenhagen Denmark. WHO/UNICEF TECHNICAL BRIEFING SEMINAR, GENEVA 4 November 2010.

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Medicine Supply Systems Strengthening Access to Medicines .

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  1. Medicine Supply Systems Strengthening Access to Medicines. Henrik K.Nielsen Technical Specialist Essential Medicines Unit - Medicines and Nutrition Centre UNICEF Supply Division, Copenhagen Denmark WHO/UNICEF TECHNICAL BRIEFING SEMINAR, GENEVA 4 November 2010

  2. Where do UNICEF SD supply medicines • UNICEF country programmes • Procurement Service Customers UN agencies NGO's MOH

  3. TOTAL PROCUREMENT (Pharmaceuticals) * As per mid October 2010

  4. TOTAL PROCUREMENT, TOP 10

  5. UNICEF Quality system is based on • Division and Centre Procedures • Principles of WHO Model QA system for Procurement TRS 937 Annex 6 is implemented • ISO 9000:2001

  6. Manufacturers of Pharmaceuticals • Manufacturers:  Review of submitted documents (Technical Questionnaire)   Export experience License to manufacture pharmaceuticals Financial status

  7. Pre-qualification –Pharmaceuticals • Pharmaceutical Products Two scenarios: 1. WHO Prequalified Pharmaceuticals 2. Assessed in UNICEF SD

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

  9. Pre-qualification of products for none WHO prequalified products • Interagency Product Questionnaire: •  Full International Non-proprietary Name • (INN name)/No brand or trade name • GMP Certificate • Manufacturing license in country of origin • Regulatory situation in country of origin and in other countries • Certificate of Pharmaceutical Product (CPP) • API , References to Pharmacopeias and CEP/DMF. CoA and GMP certificate. • Specifications for Finished Pharmaceutical Products (reference:Ph. Int, /Ph.Eur/BP or USP) and specific monographs where applicable • CoA’s of 3 production batches • Stability studies of the Finished Pharmaceutical Product • Language requirements: English and French unless other specified • Expiry date format: dd/mm/yyyy • Sample • Based on assessment: Conclusion: Acceptable/Not Acceptable

  10. GMP inspections by UNICEF • 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 • 89 GMP inspections carried out in 2006-2009. 30 % failed • Detailed GMP inspection report forwarded to company (respond within 1 month) • All manufacturers with contract are GMP inspected at regular intervals- normally every 2-5 years

  11. Products received in the warehouse are always quality 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

  12. Quality control of direct shipments • Pre-delivery inspections Third party, Country Office • Review of packaging list and CoA • Random quality control testing in accordance with prior experience

  13. Local procurement/Production • All local procurement of pharmaceuticals requires approval from UNICEF SD • Products form local manufacturers has been evaluated in countries like: • Bangladesh, India, Ethiopia, Indonesia, Peru

  14. Thank You

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