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UNICEF Medicines Supply Strengthening
WHO/UNICEF Technical Briefing Seminar on Essential Medicines PoliciesTuesday 30 October 2012Technical Specialist Henrik K.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division
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UNICEF
.
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About the Copenhagen warehouse
• Over 20,000 m2, 36,000 pallets• Fully automated
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Major commodity groups 2011
(millions of US$)
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Supplies then and now
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Where UNICEF supplies are used
by value/percentage
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Top supplier countries 2011
(millions of US$)
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Where we are
Supply Division: Copenhagen, New York
Supply hubs: Panama, Dubai, ShanghaiField warehouses by value of inventory, in US$’
Where does UNICEF SD supply medicines
• UNICEF country programmes
• Procurement Services Customers
UN Agencies
NGO’s
MOH
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UNICEF Quality system is based on
• Division and Centre Procedures
• Principles of WHO Model QA systems for
Procurement,TRS 937 Annex is implemented
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Pre-qualification - Pharmaceuticals
• Manufacturers
Review of submitted documentation
( Technical Questionnaire)
Export experience
License to manufacture pharmaceuticals
Financial status
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Pre-qualification - Pharmaceuticals
• Pharmaceutical Product:
• Two scenarios:
1. WHO Prequalified Pharmaceuticals
2. Assessed in UNICEF SD
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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
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Pre-qualification – Pharmaceuticalsfor none WHO prequalified products
• Complete Interagency Pharmaceutical Product Questionnaire for manufacturers (Product Questionnaire as in Model QA system WHO TS 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
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GMP inspections by UNICEF SD
• 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
• 100 GMP inspections carried out 2007-2012. 19 Companies failed
• Detailed GMP inspection report forwarded to the company with request to respond within 1 month.
• All manufacturers with contract are GMP inspected at regular interval – normally every 2-5 years
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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
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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
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Quality control testing
• Analysis performed on a random basis according to an annual plan
• Analysis performed by contract laboratory
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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
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Local procurement
• All local procurement of pharmaceuticals
requires approval from UNICEF SD
• Products from local manufacturers have been evaluated in countries like:
• Bangladesh, India
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Thank you www.unicef.org/supply
Thank you www.unicef.org/supplyhnielsen@unicef.org
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