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1、QA /QC including issues related to GF policies and prequalification :general principlesTruls EriksenTechnical OfficerHIV/AIDS and STIWHO Western Pacific Regional Office1Overview of presentation Introduction Determinants of quality/QA GFATM policy on QA WHO prequalification project QC Conclusion2What
2、 is quality? Fitness for purpose Fulfilling of needs Compliance with specifications3What is quality assurance? QA is the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use; “Quality assurance is about ge
3、tting it right “4Determinants of Product QualityDeterminants of Product Quality Active ingredients Inactive ingredients Packagingimmediate and external Labeling./packet inserts/Product information Handling and storage conditions Product manufacture Equipment and maintenance Plant environment Manufac
4、turing process Quality control program Product formulationProduct=specific medicine manufactures at a specific site Product=medicine in container with label, packaging insert and information5Product SelectionProcurementStorage/distributionUseProd.Specs.PrequalificationTender contractMonitoring of su
5、pplier performanceGSP,GDPInspections/licensingQAStorage/handlingGMP, inspection and licensingEvaluation of product dossier6Critical Elements in QA for ProcurementCritical Elements in QA for Procurement Product selection Supplier prequalification Product certification Contract specifications Inspecti
6、on of shipments Laboratory testing Appropriate storage, transport, dispensing, and use procedures Product monitoring/ reporting system7Guide to the Global Funds Policies onGuide to the Global Funds Policies onProcurement and Supply Management Procurement and Supply ManagementBuilding on:Interagency
7、Guidelines: Operational Principles for Good Pharmaceutical Procurement. WHO, Geneva, 1999. WHO/EDM/PAR/99.5.8Guide to the Global Funds Policies onGuide to the Global Funds Policies onProcurement and Supply Management Procurement and Supply ManagementBefore May 2005:Products bought using GF must be:W
8、HO prequalified; orApproved by Stringent Regulatory Authority; orApproved by National Regulatory AuthorityAfter May 2005:WHO prequalified; orApproved by Stringent Regulatory AuthorityQuality standard has been raised !9Guide to the Global Funds Policies onGuide to the Global Funds Policies onProcurem
9、ent and Supply Management Procurement and Supply ManagementQuality assurance refers to the management activities required to ensure that the medicines (or other health products) that reach patients are safe, effective and acceptable to the patient. These activities may include, but are not limited t
10、o, (drug) registration, pre-qualification and quality control. 10Pharmaceuticals procured with Global Fund resources are subject to authorization by the National Drug Regulatory Authority (NDRA) in the country in which they are used, following its standard practices for drug registration (or other f
11、orms of authorization, such as authorizations for special use) for pharmaceutical products.Guide to the Global Funds Policies onGuide to the Global Funds Policies onProcurement and Supply Management Procurement and Supply Management11Multi-source pharmaceutical products are off-patent products that
12、have a prior history of safe and efficacious use. Multi-source pharmaceutical products tend to be available from a wide range of manufacturers around the world.For such multi-source products, there are no additional requirements other than verification of compliance with quality standards must be co
13、nducted in accordance with relevant requirements of the NDRA in the recipients country.Guide to the Global Funds Policies onGuide to the Global Funds Policies onProcurement and Supply Management Procurement and Supply ManagementMulti-source pharmaceutical productsMulti-source pharmaceutical products
14、12Products that are available only from a single supplier, normally the originator company, are referred to as single source products. If in addition to the single supplier there are a limited number of other suppliers, the product is referred to as a limited-source product. Many of the antiretrovir
15、als and antimalarials belong to the latter category.Guide to the Global Funds Policies onGuide to the Global Funds Policies onProcurement and Supply Management Procurement and Supply Management Single and limited-source pharmaceutical productsSingle and limited-source pharmaceutical products13Grant
16、funds may be used to procure a single- or limited- source pharmaceutical product provided that such product meets one of the following standards:a) Have been found to be acceptable by the UN Procurement Quality and Sourcing Project (also known as the WHO Prequalification Project ); orb) Have been authorized for consumption in their country by a stringent regulatory authorityc) Have been authorized b
