IDA FOUNDATION IDA ARV BV Partners in Affordable Healthcare .


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. Motivation. Presentation IDA FOUNDATIONIDA ARV BVSUPPLY OF MEDICINESQA/QC SYSTEMPAPERWORKCONCLUSION. IDA FOUNDATION. The world\'s driving not-revenue driven supplier of prescriptions and restorative supplies to creating nations
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IDA FOUNDATION & IDA ARV BV Partners in Affordable 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 world\'s driving not-revenue driven provider of medications and restorative supplies to creating nations " To give amazing fundamental medications and therapeutic supplies at the most minimal conceivable cost to non-benefit social insurance associations in creating nations ." one-stop search for basic medications, diagnostics & supplies

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ESTABLISHMENT IDA ARV BV Jan 2004 Focus on the particular issues & challenges identified with ARV & HIV/AIDS restorative supplies acquirement Centralisation information in the accompanying ranges: licenses & enrollment coordinations sourcing one-stop look for ARV\'s, OI\'s & Diagnostics

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ARV PROJECTS ARV\'s are currently routinely provided to ventures in more than 24 nations 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 

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SUPPLY of\'s ARV extends regularly request a blend of generics and marked items GENERIC BRANDED Produced in creating world Produced in Western Europe/US Independent QA & QC QA &QC by maker FDC\'s available Combination of various tablets

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QA\QC at IDA Standardized & Controlled QA/QC framework bringing about top notch IDA prescriptions To sift through substandard solutions No involvement with fake meds Note: IDA name replicated (2 cases)

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Quality Assurance Quality Control* Qualification Manufacturer Qualification Product Batch Control Approval Product Specification Check soundness (BE) information and timeframe of realistic usability Verification testament of pharmaceutical item Check pressing, naming & handouts Verification nature of tests * Check extra necessities Verify WHO Pre-capability doc Check GMP status GMP review by IDA drug specialist Physical control of group Verification API Control authentications of investigation At –random synthetic examination Verifying item strong qualities Trend investigation * By autonomous contract lab QA/QC

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QA/Qualification producer GMP Manufacturing process Equipment and upkeep Plant outline and environment Personnel and preparing Documentation Handling and capacity condition Special shipment for keep cool things (IDA has 4 classes from *a to ***) Controlled temperature in distribution centers (IDA and customer) Good administering hone

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QA/Qualification item Design of the item Drug detailing Active fixing (API) Inactive fixing Bio-accessibility (rate and stretch out of assimilation) Assessments of CRO\'s Stability Packaging: Immediate and External Labeling & Information pamphlet Documented proof Validated techniques for control & generation Registration dossier

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QC/Product cluster control Physical control Verification API Control declaration of investigation At irregular concoction investigations Manufacturer – site mix check Verifying item dependable qualities Trend investigations Document number Authorisation marks Referral to Pharmacopeia (eg. UK or US) Any additional substances Form and quality

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IDA Product presentation Label International Nonproprietary Name (INN) Strength Dosage frame Route of organization (parenterals) Storage conditions Batch mfd exp Packsize Other

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Product presentation Shipper containers No item names (to avert burglary) IDA code number, group number and exp date Strong quality

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GUIDELINES IDA ARV BV agreeable with WHO rules Antiretrovirals must: Have been acknowledged by the WHO prequalification extend; or Have been approved for utilization by a stringent administrative specialist; or Have been approved by the NDRA in the beneficiary\'s nation. Choice c. is appropriate just until April 2005, pending a Global Fund Board choice

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HANDLING PAPERWORK Expertise and experience for required fare documentation e.g.: Packing List Certificates of Analysis Airway charge Required documentation for assessment exclusions Registration prerequisites in nations Service Language naming & flyers INCO Terms Payment conditions Currency Pricing necessities (e.g. Clinton Foundation)

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CONCLUSION One stop shop Standardized 3-stage QA/QC framework Knowledge about enlistment potential outcomes Experience & Expertise PLEASE NOTE THAT IDA FOUNDATION ALSO HAS AN EXTENDED RANGE FOR OPPORTUNISTIC INFECTIONS,TB & MALARIA

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BURUNDI CAMBODIA EAST TIMOR EL SALVADOR ERITREA ETHIOPIA GEORGIA GHANA GUINEE-EQ. HAITI HONDURAS IVORY COAST KENYA LESOTHO MOLDOVA MOZAMBIQUE NICARAGUA PERU SUDAN TANZANIA UKRAINE  UZBEKISTAN ZIMBABWE

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