Quality throughout the supply chain by Ruttenberg, IDA Foundation
-
Upload
achapkenya -
Category
Documents
-
view
111 -
download
4
Transcript of Quality throughout the supply chain by Ruttenberg, IDA Foundation
![Page 1: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/1.jpg)
Quality throughout the Supply Chain – 24 febr 2015
Leontien Ruttenberg MSc MBA
![Page 2: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/2.jpg)
Presentation outline
• Introduction to IDA Foundation
• Achievements & challenges in supply chain
• Maintaining quality throughout supply chain
• Proud but humble
![Page 3: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/3.jpg)
• 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
![Page 4: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/4.jpg)
• 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
![Page 5: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/5.jpg)
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:
![Page 6: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/6.jpg)
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
![Page 7: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/7.jpg)
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
![Page 8: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/8.jpg)
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
![Page 9: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/9.jpg)
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
![Page 10: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/10.jpg)
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
![Page 11: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/11.jpg)
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
![Page 12: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/12.jpg)
DEMAND PRODUCT & STOCK
DISTRIBUTION
Quality throughout the supply chain
![Page 13: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/13.jpg)
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:
![Page 14: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/14.jpg)
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
![Page 15: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/15.jpg)
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
![Page 16: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/16.jpg)
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
![Page 17: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/17.jpg)
Quality in demand forecasting
Quantification (country, program, LTAs)
Planning (production lead times)
Guidelines (anticipate to changes)
Funding
Conflict/disaster
Parallel Market
![Page 18: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/18.jpg)
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)
![Page 19: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/19.jpg)
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
![Page 20: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/20.jpg)
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
![Page 21: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/21.jpg)
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
![Page 22: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/22.jpg)
When everything has been delivered........at the far end of
supply chain
![Page 23: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/23.jpg)
Quality time …..
![Page 24: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/24.jpg)
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
![Page 25: Quality throughout the supply chain by Ruttenberg, IDA Foundation](https://reader034.fdocuments.in/reader034/viewer/2022042701/55ac0a061a28ab07388b45e3/html5/thumbnails/25.jpg)
Any Feedback / Questions?
Contact: [email protected]
www.idafoundation.org Join us on:
IDA.Foundation.Amsterdam
IDA_Foundation