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Quality throughout the Supply Chain – 24 febr 2015
Leontien Ruttenberg MSc MBA
Presentation outline
• Introduction to IDA Foundation
• Achievements & challenges in supply chain
• Maintaining quality throughout supply chain
• Proud but humble
• Our Mission:
“To improve access to and deliver high-quality essential medicines and medical supplies at the lowest possible price to low- and middle- income countries”
• Our Vision:
“Creating a world with accessible quality healthcare products for all”
• Some key facts:
– 1972: Founded by Dutch pharmacy students
– 2014: Customers in 140+ countries
– Programmes €490 million (preliminary 2014)
Introducing IDA Foundation
40 Years of Making Quality Healthcare Affordable
• Global representation (IDA offices and 40+ agents)
• 175 employees
• Specialised, multilingual team dedicated to our mission
Global network
World's leading not-for-profit supplier of essential, quality-assured medicines and medical supplies to low- and middle-income countries
Procurement Services
• Handling quality assurance and control,
transport / logistics, stock keeping
• Tendering amongst suppliers, freight
forwarders and laboratories
• Dedicated procurement and service teams
Experienced in managing entire procurement
process for global / national programs,
including:
Wholesale Services
• Stock (800 products on hand)
• Emergency response (24/7)
• Flexible shipment options (air/sea/road)
• E-catalogue / formularies showing overview of products
Delivery from stock or directly from
manufacturer
Customers and partners
MULTILATERAL FUNDING
MULTILATERAL PROGRAM & FUNDING
The Global Fund to Fight Aids,
Tuberculosis and Malaria
Drug-purchasing facility (provides
funding grants) Hosted by WHO
The World Bank
World Health
Organisation
BILATERAL
NGOs & PRIVATE
FOUNDATIONS
FBOs
PRESIDENT’S
MALARIA
INITIATIVE (PMI)
President’s
Emergency
Plan for AIDS
Relief
(PEPFAR)
Clinton Health
Access Initiative
(CHAI)
GLOBAL DRUG FACILITY (GDF)
The Global Health Network
National
Ministries of
Health (MoH)
Local
NGOs
Central Medical
Stores
IDA Destination countries
Destination of IDA products
Size of orders of top 10
TOP 10 DESTINATION COUNTRIES*
1. Nigeria 6. Papua New Guinea 2. India 7. China 3. Burkina Faso 8. Uzbekistan 4. D.R. Congo 9. Mozambique 5. Uganda 10. Philippines * Based on all programmes 2011-2013
IDA Suppliers
Location of IDA suppliers
Purchase value
TOP 5 SUPPLIER COUNTRIES*
1. India 2. USA 3. China 4. Switzerland 5. Japan * Based on total items purchased 2011-2013
Our Products
• Product assortment:
• 4000+ Essential medicines, Medical supplies
• (Custom-made) kits
• Stock: 850 medicines - mainly generic
Serving unmet needs in:
• HIV/Aids, Tuberculosis, Malaria
• Emergency response
• Reproductive, maternal, newborn and child health
• Neglected tropical diseases
• Non-Communicable Diseases
Achievements 2014
Product range:
• RMNCH: reviewed portfolio to include UN 13 commodities
• NCD: reviewed portfolio (CV), added 20 anti-cancer drugs to be completed in Q1, 2015
• Ebola response: protective equipment
• HIV/AIDS: increased focus to re-establish value added
Supply Chain Management
• Custom – made kitting projects / more complex supply chain solutions
• Shipped to 130+ destinations
• PPM-core (bed nets) to many difficult destinations
• Delivery by drone pilot
DEMAND PRODUCT & STOCK
DISTRIBUTION
Quality throughout the supply chain
Product
In line with our mission: • Only high-quality essential medicines and medical supplies • Good Manufacturing Practices (GMP) • Guaranteeing quality of medicines AND medical devices
Bureau Veritas
for ISO 9001:2008
Dutch Ministry of Health
for GDP/GMP
USAID for Source / Origin Waiver
Dutch Customs for AEO (2012
ECHO Humanitarian
Procurement Centre
Meeting country-specific requirements
• Regulatory filing + approval of IDA products
Filling the gap to maintain quality levels
• Value added to FBOs?
Audited by:
Guaranteed quality for pharmaceuticals and medical supplies*
(*process may vary depending on risk class)
• More than quality control ‘on paper’ verification audits, samples
• Leading in quality innovation: role in MQAS, WHO working groups
• IDA label: registrations in destination country
• Dedicated pharmacists in our QA / QC teams in NL, Mumbai, China
IDA Quality
Why is quality assurance needed?
National Drug Regulatory Authority
not always able to guarantee quality
WHO Prequalification focuses on
HIV/AIDS, tuberculosis, malaria
Stringent Drug Regulatory Authorities
have in-country focuses (e.g. USFDA)
Complete product range &
Comprehensive quality system
spanning the entire supply chain
IDA Quality: Filling the gaps
Quality in product & stockkeeping
Quality assurance of products
• From API to finished product incl packaging & label
• Stock keeping, shelf-life requirements, lead time
• African manufacturing – price differences w/ Asian generics
• Registration
Standardization in medical devices
• No standard list
• No standard quality guidelines
Quality
• Bioequivalence studies
• Harmonization QA guidelines
• African manufacturing – quality standards
Quality in demand forecasting
Quantification (country, program, LTAs)
Planning (production lead times)
Guidelines (anticipate to changes)
Funding
Conflict/disaster
Parallel Market
Quality in distribution
Good Distribution Practices (GDP)
GDP implementation: temperature data logger
Custom made kitting
Consolidation & kitting in flexible GMP warehousing
Pre-clearance shipments
Registration in country
Sailing times (110 destinations)
Buffer stock on hand (GDP)
DEMAND PRODUCT
DISTRIBUTION
Quality throughout the supply chain
Quantification
Planning
Guidelines
Funding
Conflict/disaster
Unmet needs
Buffer stock
Qualification
Multiple sources
API monitoring
Installed capacity
Vendor reviews
Registrations
Sailing times
Pre-shipment
Customs
Documentation
Example: Papua New Guinea (AusAid)
Essential Health Kits – two year program
• One Health Centre kit contains medicines and medical supplies for the
treatment of 5,000 patients during a period of 4 months
• 130 different health products (medicines and medical supplies) were
sourced from 55 different manufacturers
• Kitting partnership (with SDV) in Singapore
• Shipped 394 20ft containers to 6 ports in PNG
• On-time deliveries, ready for distribution across PNG’s 20 provinces
• 743 health centres and 1995 aid posts received essential health kits
Example: IMA World Health - DRC
• Award through transparent RFP process
• World Bank and DFID funding
• Essential medicines and medical supplies
• PEP kits (custom made),
• HIV/Aids tests (cold, short shelf-life),
• Diagnostics (standardization)
• Supply Chain: from stock and direct from
manufacturer to port or in country
• Pre-packaged/color coded /labelled for RDC
When everything has been delivered........at the far end of
supply chain
Quality time …..
Summary
• IDA continues to passionately serve unmet needs
• IDA quality assurance systems has been
recognized by many authorities
• Not for profit, independant & transparant
• Looking forward to renewed role with FBOs
• Partnership approach
Any Feedback / Questions?
Contact: [email protected]
www.idafoundation.org Join us on:
IDA.Foundation.Amsterdam
IDA_Foundation