Quality throughout the supply chain by Ruttenberg, IDA Foundation

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: lruttenberg@idafoundation.org

www.idafoundation.org Join us on:

IDA.Foundation.Amsterdam

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