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