Скачать презентацию Medicine Supply Systems Strengthening Access to Medicines Скачать презентацию Medicine Supply Systems Strengthening Access to Medicines

192ee54705300e68dee536e9ce222a69.ppt

  • Количество слайдов: 14

 Medicine Supply Systems Strengthening Access to Medicines. Henrik K. Nielsen Technical Specialist Essential 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

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

TOTAL PROCUREMENT (Pharmaceuticals) 2008 Pharmaceuticals 2009 2010* $ 135. 017. 400 $ 175. 651. TOTAL PROCUREMENT (Pharmaceuticals) 2008 Pharmaceuticals 2009 2010* $ 135. 017. 400 $ 175. 651. 300 $160. 107. 104 * As per mid October 2010

 TOTAL PROCUREMENT, TOP 10 2008 1 2 3 4 2009 2010* Zidovudine/Lamivudine/Nevirapine: 300 TOTAL PROCUREMENT, TOP 10 2008 1 2 3 4 2009 2010* Zidovudine/Lamivudine/Nevirapine: 300 /150/200/PAC 60 Stavudine/Lamivudine/Nevirapine: 3 0/150/200/PAC-60 Efavirenz 600 mg /PAC 30 Stavudine/Lamuvidine/Nevirapine 30/150/200 mg tabs/PAC-60 gb Artemetheter/Lumefantrine 20 mg/120 mg tab/24/PAC-30 Artemeter/Lumefantrin: 20/120 mg 6 x 4/PAC-720 Artemeter/Lumefantrine, 20/120 mg tab, 6 x 4/PAC-720 Zidovudine/Lamivudine/Nevirapine 300/150/200 mg tabs/PAC-60 gb Zidovudine/Lamivudine/Nevirapine 300+150+200 mg tabs/PAC-60 gb Efavirenz 600 mg tabs/PAC-30 Stavudine+Lamuvidine+Nevirapine 30/150/200 mg tabs/PAC-60 gb Efavirenz 600 mg tabs/PAC-30 Zinc 20 mg tablets/PAC-100 Zidovudine /Lamivudine 300/150 mg tabs/PAC-60 gb Mebendazole 500 mg tabs/PAC-100 6 Iodized oil 200 mg caps/PAC-1500 Oral reh. salts, new formula, 1 L s/CAR 1000 Micronutrient, film-coated tabs/PAC 1000 7 Sulfameth. +trimeth. 400+80 mg tabs/PAC-500 Mebendazole 500 mg tabs/PAC-100 Sulfameth. +trimeth. 400+80 mg tabs/PAC-500 8 Micronutrient, film-coated tabs/PAC -1000 Tenofovir 300 mg tabs/PAC-30 gb Amoxicillin 250 mg caps/tabs/PAC 1000 9 Mebendazole 500 mg tabs/PAC 100 Albendazole 400 mg tabs/PAC-100 Zidovudine 300 mg tabs/PAC-60 1 0 Artesunate 50 mg+Amodiaquine 153 cobl, tab/12+12/PAC-10 Disinfectants/antiseptics Oral reh. salts, new formula, 1 L s/CAR-1000 5

UNICEF Quality system is based on • Division and Centre Procedures • Principles of 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

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

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

Pre-qualification -Pharmaceuticals • WHO Prequalification of suppliers of Vaccines, HIV/AIDS, malaria and TB products 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

Pre-qualification of products for none WHO prequalified products • Interagency Product Questionnaire: • • 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. Co. A and GMP certificate. Specifications for Finished Pharmaceutical Products (reference: Ph. Int, /Ph. Eur/BP or USP) and specific monographs where applicable Co. A’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

GMP inspections by UNICEF • Principles of Quality System for GMP inspections in accordance 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

Products received in the warehouse are always quality inspected Visual inspection: Product Dosage form Products received in the warehouse are always quality inspected Visual inspection: Product Dosage form and strength Quantity Co. A: Satisfactory remaining shelf-life Manufactured by the approved site Random quality control in accordance with plan

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

Local procurement/Production • All local procurement of pharmaceuticals requires approval from UNICEF SD • 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

Thank You Thank You