unicef medicines supply strengthening
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UNICEF Medicines Supply Strengthening. WHO Technical Briefing Seminar on Essential Medicines and Health Products - PowerPoint PPT PresentationTRANSCRIPT
UNICEF Medicines Supply Strengthening
WHO Technical Briefing Seminar on Essential Medicines and Health ProductsTuesday 29 October 2013 Technical Specialist Henrik K.Nielsen, Medicines and Nutrition Centre, UNICEF Supply Division
2
UNICEF
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About the Copenhagen warehouse• Entirely controlled by
computer• 9300 m2 • 150m Long x 62m
Wide x 24m High • 36,000 pallet
locations • 8 robot cranes • Each crane
operating 4 racks • Each crane
operating 4500 pallets
Supply in the UNICEF structure
Major commodity groups
2012: $2.468 billion in supplies and services
Approximately $1.13 billion funded via Procurement Services (procurement on behalf of governments and other partners)
Supplier countries
Where we are
• 855 staff• 135 nationalities• 163 offices• 99 countries
Panama
Dubai Shanghai
Where does UNICEF SD supply medicines
• UNICEF country programmes
• Procurement Services Customers UN Agencies NGO’s MOH
UNICEF Quality system is based on
• Division and Centre Procedures
• Principles of WHO Model QA systems for Procurement, TRS 937 Annex is implemented
Pre-qualification - Pharmaceuticals
• Manufacturers Review of submitted documentation ( Technical Questionnaire) Export experience License to manufacture pharmaceuticals Financial status
Pre-qualification - Pharmaceuticals
• Pharmaceutical Product:
• Two scenarios: 1. WHO Prequalified Pharmaceuticals 2. Assessed in UNICEF SD
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
Pre-qualification – Pharmaceuticals non- WHO prequalified productsComplete Interagency Pharmaceutical Product Questionnaire for manufacturers (Product Questionnaire as in Model QA system WHO TRS 937):Full International Non-proprietary Name (INN name)No brand or trade nameGMP certificate of FPP Manufacturing siteMarketing Authorisation in country of origin, and exporting countries if applicable Certificate of Pharmaceutical product (CPP)API, Reference to Pharmacopeias and CEP/DMFGMP 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 ProductLanguage requirements: English and French unless other specifiedSample for evaluation
GMP inspections – by UNICEF SD
• Decision based on the regulatory environment In country of origin and prior experience of UNICEF• GMP inspection by UNICEF or a representative selected by
UNICEF• Contracts Manufacture only accepted if subcontractor
also is approved by UNICEF• WHO GMP guidelines used as reference• 100 GMP inspections carried out in 2007-2012. 19 companies
failed• Detailed GMP inspection report forwarded to company with
request to respond within 1 month
GMP inspections – Continued
• All manufacturers with contract are GMP inspected at regular intervals – normally every 2- 5 year
• Local authority invited to participate• Joint inspections with WHO, ICRC, MSF• UNICEF is a partner to the Pharmaceutical Inspections Cooperation Scheme (PIC-S)• UNICEF use available information to waive UNICEF inspections
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
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
Quality control - testing
• Analysis performed on a random basis according to an annual plan
• Analysis performed by contract laboratory
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
Local procurement
• All local procurement of pharmaceuticals requires approval from UNICEF SD
• Products from local manufacturers have been evaluated in countries like:
• Bangladesh, India
Thank you