connie van marrewijk-id foundation

8/12/2019 Connie Van Marrewijk-ID FOUNDATION

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IDA FOUNDATION & IDA ARV BV

Partners in A ffordab le Healthcare

Connie van Marrewijk

IDA Foundation


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AGENDA

INTRODUCTION IDA FOUNDATION

IDA ARV BV

SUPPLY OF MEDICINES

QA/QC SYSTEM

PAPERWORK

CONCLUSION


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IDA FOUNDATION

The worlds leading not-for-profit supplier of medicinesand 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


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ESTABLISHMENT IDA ARV BVJan 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


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QA\QC at IDA

Standardised & Controlled QA/QC system resulting inhigh quality IDA medicines

To filter out substandard medicines

No experience with counterfeit medicines

Note: IDA label copied (2 cases)


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QA / QC

Verify WHO Pre-qualification doc

Check GMP status

GMP audit by IDA pharmacist

QualificationManufacturer

QualificationProduct

Approval Product Specification

Check stability (BE) data and shelf life

Verification certificate ofpharmaceutical product

Check packing, labelling & leaflets

Verification quality of samples*

Check additional requirements

Product BatchControl

Physical control of batch

Verification API

Control certificates of analysis

Atrandom chemical analysis

Verifying product stabilities

Trend analysis

* By independent contract laboratory

Quality Assurance Quality Control*


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QA / Qualification manufacturer

GMP

oManufacturing process

oEquipment and maintenance

oPlant design and environment

oPersonnel and training

oDocumentation

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


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IDA Product presentation

LabelInternational Nonproprietary Name (INN)

Strength

Dosage formRoute of administration (parenterals)

Storage conditions

Batch mfd exp

Packsize

Other


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Product presentation

Shipper cartons

No product labels (to prevent theft)

IDA code number, batch number and

exp date

Strong quality


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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 regulatoryauthority; or

b. Have been authorized by the NDRA in the recipients country.

Option c. is applicable only until April 2005, pending a Global FundBoard decision


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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)


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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


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BURUNDICAMBODIA

EAST TIMOR

EL SALVADOR

ERITREAETHIOPIA

GEORGIA

GHANA

GUINEE

GUINEE-EQ.

HAITIHONDURAS

IVORY COAST

KENYALESOTHO

MOLDOVA

MOZAMBIQUENICARAGUA

PERU

SUDAN

TANZANIA

UKRAINE

UZBEKISTANZIMBABWE

connie van marrewijk-id foundation

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