UNICEF Medicines Supply Strengthening WHO Technical Briefing Seminar on Essential Medicines and Health Products Tuesday 29 October 2013 Technical Specialist.

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

.

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 products

Complete 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