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 .
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
• 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