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 world’s 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 ARV’s, OI’s & Diagnostics

ARV PROJECTS ARV’s 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 TanzaniaMozambique Peru Úkraine

SUPPLY of ARV’s ARV projects often demand a mixture of generics and branded products GENERICBRANDED Produced in developing worldProduced in Western Europe / US Independent QA & QC QA &QC by manufacturer FDC’s 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 AssuranceQuality Control*

QA / Qualification manufacturer GMP o oManufacturing process o oEquipment and maintenance o oPlant design and environment o oPersonnel and training o oDocumentation Handling and storage condition o oSpecial shipment for keep cool items (IDA has 4 classes from *a to ***) o oControlled temperature in warehouses (IDA and client) o oGood dispensing practice

QA / Qualification product Design of the product o oDrug formulation o oActive ingredient (API) o oInactive ingredient o oBio-availability (rate and extend of absorption) o oAssessments of CRO’s o oStability o oPackaging: Immediate and External o oLabelling & Information leaflet o oDocumented evidence o oValidated methods of control & production o 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 recipient’s 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

BURUNDICAMBODIA EAST TIMOR EL SALVADOR ERITREAETHIOPIAGEORGIAGHANAGUINEEGUINEE-EQ.HAITI HONDURAS HONDURAS IVORY COAST KENYALESOTHOMOLDOVAMOZAMBIQUENICARAGUAPERUSUDANTANZANIAUKRAINE UZBEKISTANZIMBABWE