IDA FOUNDATION & IDA ARV BVIDA FOUNDATION & IDA ARV BV

Partners in Affordable HealthcarePartners in Affordable Healthcare

Connie van Marrewijk

IDA Foundation

AGENDAAGENDA

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

IDA FOUNDATIONIDA 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 BVESTABLISHMENT IDA ARV BVJan 2004Jan 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 PROJECTSARV PROJECTS

ARV’s are now routinely supplied to projects in over 24 countries

Global FundCambodiaEl Salvador Other ProjectsEthiopia BurundiGeorgia EritreaGhana East TimorHaiti Kenya Honduras Guinee-Eq.Ivory Coast UzbekistanNicaragua ZimbabweLesotho Guinee Moldova SudanTanzania MozambiquePeru Úkraine 

SUPPLY of ARV’sSUPPLY of ARV’s

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

FDC’s available Combination of different tablets

QA\QC at IDAQA\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 / QCQA / 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 manufacturerQA / 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

QA / Qualification productQA / Qualification product

Design of the productoDrug formulationoActive ingredient (API)oInactive ingredientoBio-availability (rate and extend of absorption)

oAssessments of CRO’soStabilityoPackaging: Immediate and ExternaloLabelling & Information leafletoDocumented evidence

oValidated methods of control & productionoRegistration dossier

QC / Product batch controlQC / Product batch control

Physical controlVerification APIControl certificate of analysisAt random chemical analysesManufacturer – site combination checkVerifying product stabilitiesTrend analysesDocument numberAuthorisation signaturesReferral to Pharmacopeia (eg. UK or US)Any added substancesForm and strength

IDA Product presentationIDA Product presentation

LabelInternational Nonproprietary Name (INN)StrengthDosage formRoute of administration (parenterals)Storage conditionsBatch mfd expPacksizeOther

Product presentation

Shipper cartons

No product labels (to prevent theft)

IDA code number, batch number and exp date

Strong quality

GUIDELINESGUIDELINES

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 PAPERWORKHANDLING 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)

CONCLUSIONCONCLUSION

• 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

BURUNDIBURUNDICAMBODIACAMBODIA

EAST TIMOREAST TIMOREL SALVADOREL SALVADOR

ERITREA ERITREA ETHIOPIA ETHIOPIA GEORGIA GEORGIA GHANA GHANA GUINEEGUINEE

GUINEE-EQ.GUINEE-EQ.HAITI HAITI

HONDURASHONDURASIVORY COAST IVORY COAST

KENYAKENYALESOTHO LESOTHO MOLDOVA MOLDOVA

MOZAMBIQUEMOZAMBIQUENICARAGUA NICARAGUA

PERU PERU SUDANSUDAN

TANZANIA TANZANIA UKRAINE UKRAINE 

UZBEKISTANUZBEKISTANZIMBABWE ZIMBABWE