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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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Presentation Transcript
slide1

IDA FOUNDATION & IDA ARV BV

Partners in Affordable Healthcare

Connie van Marrewijk

IDA Foundation

slide2

AGENDA

  • INTRODUCTION IDA FOUNDATION
  • IDA ARV BV
  • SUPPLY OF MEDICINES
  • QA/QC SYSTEM
  • PAPERWORK
  • CONCLUSION
ida foundation
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
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

arv projects
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 

supply of arv s
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

qa qc at ida
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

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
qa qualification manufacturer
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
qa qualification product
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
qc product batch control
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
IDA Product presentation
  • Label
  • International Nonproprietary Name (INN)
  • Strength
  • Dosage form
  • Route of administration (parenterals)
  • Storage conditions
  • Batch mfd exp
  • Packsize
  • Other
slide13

Product presentation

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

handling paperwork
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
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
slide17

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