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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. - PowerPoint PPT Presentation
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Medicine Supply Systems Strengthening
Access to Medicines.
Henrik K.NielsenTechnical Specialist
Essential Medicines Unit - Medicines and Nutrition CentreUNICEF Supply Division, Copenhagen Denmark
WHO/UNICEF TECHNICAL BRIEFING SEMINAR, GENEVA4 NOVEMBER 2010
Where do UNICEF SD supply medicines
• UNICEF country programmes
• Procurement Service CustomersUN agenciesNGO'sMOH
TOTAL PROCUREMENT (Pharmaceuticals)
2008 2009 2010*
Pharmaceuticals $ 135.017.400 $ 175.651.300 $160.107.104
* As per mid October 2010
TOTAL PROCUREMENT, TOP 10 2008 2009 2010*1 Stavudine+Lamuvidine+Nevirapine
30/150/200mg tabs/PAC-60 gbZidovudine/Lamivudine/Nevirapine:300/150/200/PAC 60
Stavudine/Lamivudine/Nevirapine:30/150/200/PAC-60
2 Efavirenz 600 mg /PAC 30Stavudine/Lamuvidine/Nevirapine 30/150/200mg tabs/PAC-60 gb
Artemetheter/Lumefantrine20mg/120mg tab/24/PAC-30
3
Artemeter/Lumefantrin: 20/120mg6x4/PAC-720
Artemeter/Lumefantrine,20/120mg tab,6x4/PAC-720
Zidovudine/Lamivudine/Nevirapine300/150/200mg tabs/PAC-60 gb
4Zidovudine/Lamivudine/Nevirapine 300+150+200mg tabs/PAC-60 gb
Efavirenz 600mg tabs/PAC-30 Efavirenz 600mg tabs/PAC-30
5 Zinc 20mg tablets/PAC-100Zidovudine /Lamivudine 300/150mg tabs/PAC-60 gb Mebendazole 500mg tabs/PAC-100
6 Iodized oil 200mg caps/PAC-1500Oral reh.salts,new formula,1L s/CAR-1000
Micronutrient,film-coated tabs/PAC-1000
7Sulfameth.+trimeth.400+80mg tabs/PAC-500 Mebendazole 500mg tabs/PAC-100
Sulfameth.+trimeth.400+80mg tabs/PAC-500
8Micronutrient,film-coated tabs/PAC-1000
Tenofovir 300mg tabs/PAC-30 gb
Amoxicillin 250mg caps/tabs/PAC-1000
9Mebendazole 500mg tabs/PAC-100 Albendazole 400mg tabs/PAC-100 Zidovudine 300mg tabs/PAC-60
10
Artesunate 50mg+Amodiaquine153 co-bl,tab/12+12/PAC-10 Disinfectants/antiseptics
Oral reh.salts,new formula,1L s/CAR-1000
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 experienceLicense to manufacture pharmaceuticalsFinancial status
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
• 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:• 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
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:ProductDosage form and strengthQuantity CoA:
Satisfactory remaining shelf-life Manufactured by the approved site
Random quality control in accordance with plan
Quality control of direct shipments
• Pre-delivery inspectionsThird party, Country Office
• Review of packaging list and CoA • Random quality control testing in accordance with prior
experience
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
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