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IDA FOUNDATION & IDA ARV BV Partners in Affordable Healthcare

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.

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IDA FOUNDATION & IDA ARV BV Partners in Affordable Healthcare

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  1. IDA FOUNDATION & IDA ARV BV Partners in Affordable Healthcare Connie van Marrewijk IDA Foundation

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

  3. 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

  4. 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 ARV’s, OI’s & Diagnostics

  5. 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 Tanzania Mozambique Peru Úkraine 

  6. SUPPLY of ARV’s ARV projects often demand a mixture of generics and branded products GENERICBRANDED Produced in developing world Produced in Western Europe / US Independent QA & QC QA &QC by manufacturer FDC’s available Combination of different tablets

  7. 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)

  8. Quality Assurance Quality Control* Qualification Manufacturer Qualification Product Product Batch Control • 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 • Verify WHO Pre-qualification doc • Check GMP status • GMP audit by IDA pharmacist • Physical control of batch • Verification API • Control certificates of analysis • At –random chemical analysis • Verifying product stabilities • Trend analysis • * By independent contract laboratory QA / QC

  9. QA / Qualification manufacturer • GMP • Manufacturing process • Equipment and maintenance • Plant design and environment • Personnel and training • Documentation Handling and storage condition • Special shipment for keep cool items (IDA has 4 classes from *a to ***) • Controlled temperature in warehouses (IDA and client) • Good dispensing practice

  10. QA / Qualification product Design of the product • Drug formulation • Active ingredient (API) • Inactive ingredient • Bio-availability (rate and extend of absorption) • Assessments of CRO’s • Stability • Packaging: Immediate and External • Labelling & Information leaflet • Documented evidence • Validated methods of control & production • Registration dossier

  11. 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

  12. IDA Product presentation • Label • International Nonproprietary Name (INN) • Strength • Dosage form • Route of administration (parenterals) • Storage conditions • Batch mfd exp • Packsize • Other

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

  14. GUIDELINES IDA ARV BV compliant with WHO guidelines Antiretrovirals must: Have been accepted by the WHO prequalification project; or • Have been authorized for consumption by a stringent regulatory authority; or • 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

  15. 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)

  16. 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

  17. 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

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