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Prequalification of HIV/AIDS products and manufacturers

Prequalification of HIV/AIDS products and manufacturers. Background: Why prequalification?. What are the problems? Millions of people living with HIV/AIDS, no access to treatment Procurement and supply of substandard and counterfeit products in different countries Weak/absent QA systems

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Prequalification of HIV/AIDS products and manufacturers

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  1. Prequalification of HIV/AIDS products and manufacturers

  2. Background: Why prequalification? • What are the problems? • Millions of people living with HIV/AIDS, no access to treatment • Procurement and supply of substandard and counterfeit products in different countries • Weak/absent QA systems • Money invested – lost • Duplication of work by different agencies • Risk: Sourcing of poor quality products, risk to patients, treatment failure, resistance

  3. Prequalification: How to get started? • Quality Assurance systems • QSM, MQAS • NGOs and other organizations • Draft 1, 2 and 3 in process • General Procedure for Prequalification • Standard Operating Procedures • Norms and standards for product dossiers and manufacturing sites

  4. Expected outcome • Partners: • UNICEF, UNFPA, UNAIDS, WHO, supported by the World Bank • WHO role: • Managing the project and provide technical support, norms and standards on product assessment, GCP, GLP, GMP • Outcome: • List of products and manufacturers meeting international norms and standards • Harmonization, co-operation, training, capacity building – NDRAs, WHO, PAs, NGOs • Facilitate access to treatment

  5. Prequalification procedure • Invitation for EOI – voluntary participation • Guidelines for product dossier compilation • Screening and assessment of dossiers and product samples • SMF and manufacturing site inspection • Reports on outcome of assessments • Assessment of additional data and information, follow up inspection • Quality control testing of samples • Listing the outcome • Ongoing assessment and monitoring

  6. Product data and information • Innovator products • Assessment report from DRA, CPP, Batch certificate, changes • Multisource products • Full dossier with data and information on quality and bio-equivalence including API details, specifications, stability data, formulation, manufacturing method, packaging, labelling etc • Sample for analysis • Assessment teams: • DRA assessors from Canada, Denmark, France, Germany, Philippines, Sweden, Switzerland, Zimbabwe and others

  7. Manufacturing sites and samples • GMP compliance • Team of inspectors: WHO plus PIC/S member DRA plus local DRA inspector(s) • Premises, equipment, QA, materials, validation, QC, documentation • Product and site specific – data verification (BMR, specifications, bio batch, validation report, dossier) • Samples tested fro compliance with dossier specifications and test methods

  8. Current status • Started March 2001 • Four EOIs including ARVs, antibiotics, anticancer, antifungal products • Ongoing assessments and follow-up (products and manufacturing sites) • March 2004: 268 product dossiers received and assessed from various manufacturers for innovator and multi-source products • Samples tested at three independent laboratories • List of prequalified products and manufacturers published • Second tender published

  9. Problems experienced • Non prequalified products (although under assessment) supplied to several countries • Product dossiers lacking data and information • API: source of API, synthesis, specifications, method validation, stability • Pharmaceutical development data • Formulation and manufacturing process, validation, stability • No bioequivalence studies or incomplete study reports • No pharmacopoeia monographs in many cases

  10. Problems experienced (cont) • Manufacturing sites not meeting GMP • Poor design, layout and construction • Lack of validation (process, utilities, equipment etc) • Hormones, antibiotics such as penicillin, in same areas • Lack of raw data • Cross-contamination and mix-ups • Lack of quality control on materials • Manufacturers have to perform studies to generate data e.g. stability, bioequivalence • Validation of manufacturing processes • Upgrading of manufacturing facilities • Different requirements and standards: local market versus export

  11. Discussion and conclusion • To date, only 97 (37%) products listed as meeting the requirements after several assessments and additional data – including innovator products • Remaining products under assessment or withdrawn • Manufacturing sites: Limited number complying • Evident: Many products marketed not meeting international requirements • Differences in requirements from country to country • Lack of assessment and quality control in countries where needed most

  12. Recommendation • 14th edition of the list published – to continue to facilitate access to wide range of products meeting international standards • Ongoing quality control, monitoring, assessment and re-qualification • Mechanisms be put in place to curb supply of counterfeit and substandard medicines • Harmonization in assessments and increased capacity building • Ensure safe, effective, quality HIV/AIDS products are purchased and supplied

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