PATH & WHO & UNFPA Workshop Prequalification Programme in Procurement Practices: Session 2 Overview of WHO Prequalification Programme

Publication date: 2008

Session 2: Overview of the WHO Prequalification Programme Prequalification • In principal: A documented process for reviewing a product or service to ensure it complies with identified criteria WHO – Prequalification is focused on criteria relevant for public health: quality, safety, efficacy, and performance • Supplier qualification systems differ in the level of product evaluation performed • Workshop is focused on the WHO Prequalification Programme for Priority Medicines and Prequalification of Condoms and IUDs (UNFPA) Presenter Presentation Notes This is a brief overview--a more in-depth look at the steps in the WHO prequalification process are included in a later session. General purpose of a prequalification process is to provide an assurance that a product has a track record of being manufactured in accordance with quality and performance requirements. The WHO Prequalification Programme is a comprehensive system, including inspection of a product manufacturing site, a rigorous review of product dossier, and ongoing monitoring to ensure that essential medicines are safe, effective. Procuring entities often have specific systems for qualifying suppliers; however, these systems are for the specific use of those agencies and they are distinctly different from what the WHO has set out to accomplish in its system. For example, many organizations qualify suppliers based on their registration status. They may also have political focus, such as preferences for countries of origin. Other Prequalification Systems • WHO Prequalification Programme for Vaccines • WHO Prequalification Programme for HIV diagnostics • WHO/UNICEF Prequalification Programme for Immunization Products • WHO Prequalification Programme for Quality Control Laboratories • Independent procurement organizations (e.g., International Dispensary Association and Missionpharma) Presenter Presentation Notes The WHO has established several systems to pre-qualify manufacturers of essential products as well as for testing laboratories for independent product inspection. A system for vaccines and related equipment, formerly known as the Product Information System, or the PIS, was revised in 2004 to become the PQS for vaccines and related equipment. Those products that conform to the PQS requirements are listed on the WHO PQS website. WHO has also established a prequalification programme for Quality Control (QC) laboratories. Approved laboratories are certified to perform independent testing of products for pre and post shipment inspections. Some NGO procurement agencies conduct their own independent prequalification process, but only for products that they procure e.g., IDA and Mission Pharma. While there may be similarities to the WHO process, those systems are intended to be internal to their own project i.e., they do not provide results for public use. WHO Prequalification Programme for Medicines • Originally the Prequalification Programme for Priority Medicines, including: HIV/AIDS, Tuberculosis, and Malaria medicines • Expanded to include reproductive health medicines, and condoms and intrauterine devices (IUDs) with UNFPA Presenter Presentation Notes The WHO Prequalification Programme for medicines was initiated in 2001 to address the immediate need to expanded access to quality medicines to treat high impact diseases such as HIV/AIDS. In 2001 tuberculosis drugs were added. In 2002, prequalification of malaria management medicines was added. A WHO study in 2003 found that the majority of countries have limited resources to adequately regulate the safety, efficacy, and quality of medicines, creating a risk for: Sub-standard, contaminated, expired, counterfeit, or other inappropriate products to enter into the country market Burden of managing product recalls Waste of limited funds Health risks to patients In 2006, the first expression of interest for products for reproductive health family planning services (hormonal contraceptives) was issued. Product Prequalification • Evaluation of product information including APIs, formulation, manufacture, quality control, and test results • Inspection and verification of data: • GCP (Good Clinical Practice) • cGMP inspections (current Good Manufacturing Practice) • Monitoring: Ongoing monitoring, variations, re-qualification, and de-listing of products Presenter Presentation Notes Product prequalification includes: a thorough review of detailed product information a thorough review and inspection by technical experts of the manufacturers production processes, quality control practices and testing requirements, and compliance with WHO-recommended current GMPs (cGMPs). Reminder: WHO looks for cGMPs, not certifications that are outdated or from non-credible agencies. Maintaining prequalified status is an ongoing activity, and not a one-time certificate. Monitoring, periodic assessments, sampling, and other safeguards are included. A product can be de-qualified if problems occur. Generally, products are qualified for a three year period. Any product changes or problems reported with the product require re-qualification. Essential Steps: Medicines • Expression of interest (EOI) is published • Interested parties submit dossiers • Dossiers receive initial screening • Full dossier assessment • Site inspections are conducted • Report on findings and recommendations is released • Evaluation results are published Presenter Presentation Notes These are the fundamental steps. A handout with more detail on each step will be provided in a later session. Expression of Interest: Published widely in the international press and posted on the WHO website at regular intervals based on need. Submission of dossiers – Manufacturers submit required product information for evaluation. Requirements vary by product and also by whether they are already registered in a country with a stringent regulatory authority, EU/EEA, US, Japan. Initial screening – If incomplete, the manufacturer is notified and given a specified time period to complete. Dossier assessment – Evaluated by a team of experts appointed by WHO from regulatory authorities including product sample testing. Site inspection – With acceptable dossiers, WHO coordinates site inspection for compliance with cGMP as recommended by WHO, including production, and quality control activities. Report – Evaluation team finalizes their report of findings and recommendations. Publication – WHO sends manufacturer a letter informing them of the outcome and a copy is sent to the national regulatory authority. If the product is accepted, it is included on the WHO list of prequalified products. If not, recommendations are provided. Ongoing monitoring after initial prequalification: • Sampling and testing • Reevaluation • Reinspection • De-listing (if and when appropriate) Essential Steps: Monitoring Medicines Presenter Presentation Notes After a product is prequalified, WHO continues to monitor product quality through: Testing of samples – In addition to the product samples submitted with the dossier, random samples of products supplied after prequalification are tested to monitor continued compliance with product requirements Reevaluation – Reevaluation of dossiers done every three years or sooner if any changes to the product, manufacturing method or site. Reinspection of manufacturers done at regular intervals at least once every three years. De-listing – If a product fails to meet the product and QA requirements it is removed from the WHO list of prequalified products UNFPA Prequalification Programme for Condoms and IUDs Background: • UNFPA began its product prequalification process in 2001 • Prequalification focuses on suppliers of condoms and IUDs • UNFPA and WHO are harmonizing prequalification processes for condoms and IUDs Presenter Presentation Notes UNFPA procures a number of reproductive health commodities; condoms, IUDs, injectables, implants, oral contraceptives, and spermicides for UNFPA programs and for country governments. In 2001, UNFPA made a decision to implement a structured prequalification program for condoms and IUDs. UNFPA and WHO are currently in the process of harmonizing UNFPA prequalification process for condoms and IUDs with the WHO process for other RH medicines in order to offer a unified, single process. Prequalification for Condoms and IUDs • Existing process based on UNFPA programme • Process is essentially similar to process for medicines, with some exceptions: ƒ Submission and evaluation of key documents versus dossier ƒ Pre-shipment sampling is a requirement for condoms Presenter Presentation Notes These are the basic steps in the current UNFPA prequalification process for condoms and IUDs. As mentioned, this process is currently being evaluated and revised for the purpose of harmonizing the procedures with the WHO processes. Some differences include: Submission of key documents versus a dossier. A dossier is not always standard process for devices, so key documents are reviewed instead of a drug dossier. Examples of key documents include: Current applicable national registration: legal status, license to produce product Certification of quality management processes, such as cGMP Description of on-site Quality Assurance (QA) laboratory facilities and range of tests conducted Testing of samples – For condoms, pre-shipment sampling and testing is a requirement for every batch. Products that have passed the tests and that have had successful factory inspections are placed on the prequalified list. Day 1: Session 2 Benefits of Using the WHO and UNFPA Prequalification Programmes Small Group Exercise Instructions to participants: 1. Work in groups of three to five people. 2. Discuss the benefits of using the WHO and UNFPA Prequalification Programmes. Brainstorm an extensive list, then discuss with the group members. The space on this page below is provided for your personal notes. 3. Select the top three benefits – ones that you think are more important or significant than the others. List these on a piece of flipchart paper. 4. Take no more than 20 minutes for discussion in your small group. 5. Assign a spokesperson to report out to the larger group. Discussion question: • What are the benefits of using the WHO and UNFPA Prequalification Programmes? A related question for discussion might be: • How could a prequalification system support your country’s national regulatory agency? Brainstorm of benefits: Select the top three most important ones: The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices Day 1: Session 2 Answer Key Prequalified Medicines Answer Key to Exercise Instructions to participants: 1. Work in groups of 3–5 people. 2. Review the list of the Prequalification Programme’s Priority Essential Medicines – Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality distributed to you by the facilitators. 3. Work together with your group to answer as many of the questions below as possible. You have approximately 15 minutes for this exercise. 4. After the exercise, an answer sheet will be distributed and you will have approximately 5–10 minutes to review and discuss with your group. 1. How many manufactures are prequalified to produce Nevirapine? 7 2. Name two medicines from these prequalified medicine lists that are included on your country’s essential medicines list or are priorities for procurement. (Multiple answers) 3. In what country is the prequalified manufacturer of Abacavir Surlfate based? India 4. Is there a prequalified manufacturer of Stavudine based in South Africa? Yes – Aspen 5. In what country is the medicine Ganciclovir manufactured? Switzerland 6. Name four medicines manufactured in India. (Many examples) Abacavir, Aciclovir, Nevirapine, Cycloserine 7. Name one medicine that comes in capsule, tablet, infusion, and solution forms. Zidovudine 8. What are the three dosages available for Aciclovir dispersable tablets? 200, 400, and 800 mg 9. Name two medicines that are manufactured by Cipla in Goa, India. Lamivudine, Nevirapine 10. Does Fluconazole come in pill form? No – capsules 11. Is Lamivudine available as an oral solution? Yes – 10 mg 12. Which medicine has the largest number of prequalified manufacturers? Lamivudine – 8 Stavudine - 8 13. Name two medicines that you order from your country’s essential medicines list that are not listed on these prequalification lists. (Multiple answers) The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices 2a - PPT - Overview of PQ Programme Session 2:�Overview of the �WHO Prequalification Programme Prequalification Other Prequalification Systems WHO Prequalification Programme for Medicines Product Prequalification Essential Steps: Medicines Essential Steps: �Monitoring Medicines UNFPA Prequalification Programme for Condoms and IUDs Prequalification for �Condoms and IUDs 2b - Exercise - Programme Benefits 2c - Exercise - Prequalified Meds 2d - Answer Key - Prequalified Meds << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /None /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB IEC61966-2.1) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Error /CompatibilityLevel 1.4 /CompressObjects /Tags /CompressPages true 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<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> /ENU (Use these settings to create Adobe PDF documents best suited for high-quality prepress printing. 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