UNICEF Medicines Supply Strengthening O/UNICEF Technical Briefing Seminar on Essential Medicines Policies esday 30 October 2012 chnical Specialist Henrik K.Nielsen, Medicines and Nutrition Centre NICEF Supply Division
Dec 31, 2015
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/[email protected]