世界卫生组织对独立贸易区和区域渔管中药品的技术要求

CONTENTS Acronyms............................................................................................................................................................................11.Backgound.................................................................................................................................................................32.Product Information...................................................................................................................................................32.3 Manufacturing sites..................................................................................................................................................52.1.Shelf life............................................................................................................................................................52.2.storage conditions along the supply chain.........................................................................................................52.3.Stability studies.................................................................................................................................................62.4.Patient Information leaflets and package inserts...............................................................................................62.5.Product Picture and samples..............................................................................................................................62.6.Quality of Goods...............................................................................................................................................72.7.Audits................................................................................................................................................................72.8.Supplier’s Responsibility for Rejected or Returned Products...........................................................................82.9.Managing Product Recalls.................................................................................................................................83.Packaging and Palletization.......................................................................................................................................83.1 Kit packaging specificity..........................................................................................................................................93.1.1.Content list and packing list.....................................................................................................................93.1.2.Kit Label...................................................................................................................................................93.1.3.Kit Standard box requirements...............................................................................................................103.1.4.Kit Cold chain packaging.......................................................................................................................114.Transport of temperature sensitive pharmaceuticals................................................................................................125.Request for Change of Product(s) or Price(s) After Award.....................................................................................136.Stocks.......................................................................................................................................................................137.Delivery information................................................................................................................................................147.1.Delivery lead time...........................................................................................................................................147.2.Receipt and confirmation of Purhcase ORDER (PO)......................................................................................147.3.Notice of delay of delivery..............................................................................................................................147.4.Handover of the goods to WHO appointed Forwarder....................................................................................157.5.Custom and shipping documents.....................................................................................................................157.6.Cargo Transport...............................................................................................................................................168.Technical documents to be submitted as annexes by bidders..................................................................................16 APIActive Pharmaceutical Ingredient(s)BLBill of LadingCPPCertificate of pharmaceutical productCOACertificate of analysisEMLWHO Model of Essential Medicines ListERPExternal Review PanelFDCfixed-dose combinationFPPFinished P