IDA FOUNDATION & IDA ARV BV

Partners in Affordable Healthcare

Connie van Marrewijk
IDA Foundation






AGENDA
INTRODUCTION IDA FOUNDATION
IDA ARV BV
SUPPLY OF MEDICINES
QA/QC SYSTEM
PAPERWORK
CONCLUSION

IDA FOUNDATION
The worlds leading not-for-profit supplier of medicines
and medical supplies to developing countries

To provide high quality essential drugs
and medical supplies at the lowest
possible price to non-profit health care
organisations in developing countries.

one-stop shop for essential drugs, diagnostics & supplies
ESTABLISHMENT IDA ARV BV
Jan 2004
Focus on the specific issues & challenges related to ARV &
HIV/AIDS medical supplies procurement

Centralisation knowledge in the following areas:
patents & registration
logistics
sourcing
one-stop shop for ARVs,
OIs & Diagnostics
ARV PROJECTS
ARVs are now routinely supplied to projects in over 24 countries

Global Fund
Cambodia
El Salvador Other Projects
Ethiopia Burundi
Georgia Eritrea
Ghana East Timor
Haiti Kenya
Honduras Guinee-Eq.
Ivory Coast Uzbekistan
Nicaragua Zimbabwe
Lesotho Guinee
Moldova Sudan
Tanzania Mozambique
Peru kraine


SUPPLY of ARVs
ARV projects often demand a mixture of generics and branded
products

GENERIC BRANDED

Produced in developing world Produced in Western Europe / US

Independent QA & QC QA &QC by manufacturer

FDCs available Combination of different tablets

QA\QC at IDA
Standardised & Controlled QA/QC system resulting in
high quality IDA medicines

To filter out substandard medicines
No experience with counterfeit medicines

Note: IDA label copied (2 cases)



QA / QC
Verify WHO Pre-qualification doc
Check GMP status
GMP audit by IDA pharmacist
Qualification
Manufacturer
Qualification
Product
Approval Product Specification
Check stability (BE) data and shelf life
Verification certificate of
pharmaceutical product
Check packing, labelling & leaflets
Verification quality of samples*
Check additional requirements

Product Batch
Control
Physical control of batch
Verification API
Control certificates of analysis
At random chemical analysis
Verifying product stabilities
Trend analysis
* By independent contract laboratory
Quality Assurance Quality Control*
QA / Qualification manufacturer


GMP
oManufacturing process
oEquipment and maintenance
oPlant design and environment
oPersonnel and training
oDocumentation

Handling and storage condition
oSpecial shipment for keep cool items (IDA has 4 classes from *a to ***)
oControlled temperature in warehouses (IDA and client)
oGood dispensing practice



QA / Qualification product



Design of the product
oDrug formulation
oActive ingredient (API)
oInactive ingredient
oBio-availability (rate and extend of absorption)
oAssessments of CROs
oStability
oPackaging: Immediate and External
oLabelling & Information leaflet
oDocumented evidence
oValidated methods of control & production
oRegistration dossier

QC / Product batch control



Physical control
Verification API
Control certificate of analysis
At random chemical analyses
Manufacturer site combination check
Verifying product stabilities
Trend analyses
Document number
Authorisation signatures
Referral to Pharmacopeia (eg. UK or US)
Any added substances
Form and strength







IDA Product presentation




Label
International Nonproprietary Name (INN)
Strength
Dosage form
Route of administration (parenterals)
Storage conditions
Batch mfd exp
Packsize
Other












Product presentation

Shipper cartons
No product labels (to prevent theft)
IDA code number, batch number and
exp date
Strong quality

GUIDELINES
IDA ARV BV compliant with WHO guidelines

Antiretrovirals must:
Have been accepted by the WHO prequalification project; or
a. Have been authorized for consumption by a stringent regulatory
authority; or
b. Have been authorized by the NDRA in the recipients country.

Option c. is applicable only until April 2005, pending a Global Fund
Board decision
HANDLING PAPERWORK
Expertise and experience for required export documentation e.g.:
Packing List
Certificates of Analysis
Airway bill
Required documentation for tax exemptions
Registration requirements in countries
Service
Language labelling & leaflets
INCO Terms
Payment conditions
Currency
Pricing requirements (e.g. Clinton Foundation)
CONCLUSION
One stop shop

Standardised 3-step QA/QC system

Knowledge about registration possibilities

Experience & Expertise

PLEASE NOTE THAT IDA FOUNDATION ALSO HAS AN
EXTENDED RANGE FOR OPPORTUNISTIC INFECTIONS,TB
& MALARIA
BURUNDI
CAMBODIA
EAST TIMOR
EL SALVADOR
ERITREA
ETHIOPIA
GEORGIA
GHANA
GUINEE
GUINEE-EQ.
HAITI
HONDURAS
IVORY COAST
KENYA
LESOTHO
MOLDOVA
MOZAMBIQUE
NICARAGUA
PERU
SUDAN
TANZANIA
UKRAINE
UZBEKISTAN
ZIMBABWE