产品发运和召回t课件

1、一、将原药品“销售” 管理的要求变化为药品“发运” 的管理，强化指制药业将产品发送到经销商或用户的一系列操作管理，包括配货、运输等活动；二、将产品“收回”按照相关法规文件通行的术语统一修订为产品“召回”；对产品召回的具体操作流程和控制要点进行详细规定；三、将原规范附录一总则中“药品零头包装只限两个批号为一个合箱”修订为仅限于在药品发运时进行合箱相关操作，避免人员的混批和差错发生。主要变化完善条款 对原79条有关药品收回管理条款，根据术语统一的原则，将“药品收回”修订为“产品召回”。完善条款 对原79条有关退货和召回的产品的处理条款进行完善，明确规定了因质量原因退货和召回产品的处理要求。完善条款

2、对原77条有关销售记录记录管理的条款进行完善，将“销售记录”修订为“发运记录”；并在发运记录内容增加“联系方式” “运输方式”等项目，保证发运药品的可溯源性。完善条款 对原规范附录一总则中有关外包装工序的合箱的规定作了调整，将合箱操作调整到发货时进行。 完善条款 本条款是对原78条有关销售记录保存期限进行修订而成。新增条款 增加对召回操作规程建立的要求。新增条款 本条款是设立产品召回人员及相关职责的相关规定。 新增条款增加有关召回启动时效性控制要求。完善条款 对原82条有关质量缺陷产品上报药品监督管理部的管理的条款进行完善，增加了召回存在安全隐患的产品向药品监督管理部门报告的要求。新增条款 增

3、加了对药品发运的要求新增条款增加对已召回产品控制的要求。新增条款 增加对召回产品处理过程记录的管理及最终报告要求。新增条款 增加对产品召回系统有效性评估的要求fda 101: product recallsfirst alert fda hears about product problems through company notification, agency inspections and adverse event reports, and through cdc. alerting the public fda posts regular updates about recalls

4、 to its web site, and all recalls appear in the agencys weekly enforcement reports effectiveness checks fda reviews all of a companys corrective actions to determinewhen a recall is complete. example: recalled biologicals by us fda date notificationbrand nameproduct descriptionreason/problemcompany1

5、2/17/2010fluvirin 1(influenza virus vaccine) 2010-2011formula multidose vialslot # 111812p1cracks in the vial necks carry the potential risk of product sterility being compromisednovartis vaccines and diagnostics, inc.cambridge, ma 01239/16/2010influenza a (h1n1) 2009 monovalent vaccinenational drug

6、 code (ndc) 49281-640-1510 5ml multidose vialsinforms health care professionals that all lots of influenza a (h1n1) 2009 monovalent vaccine in multidose vials distributed by sanofi pasteur in the u.s. will have a shorter expiration period than indicated on the label.sanofi pasteurswiftwater, pa 5/25

7、/2010gammagard liquid, immune globulin intravenous (human)14lot numbers: le12j370ab, le12j379aba precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots.baxter biosciencewestlake village, california3/25/2010influenza a (h1n1) 200

8、9 monovalent vaccine live, intranasal expiration date update16 these lots should be used by the date indicated in the table above regardless of the expiration date imprinted on the sprayer.medimmune llcphiladelphia, paexample: recalled biologicals by us fdadate notificationbrand nameproduct descript

9、ionreason/problemcompany3/22/2010prevnar, pneumococcal 7-valent conjugate vaccine180.5 ml single dose pre-filled syringe (10 per package)syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with prevnarwyethpearl river, new york2/3/2010inf

10、luenza a (h1n1) 2009 monovalent vaccine20prefilled syringes ut023aa, ut023ba, ut023ca, ut023ea, ut023faprefilled syringes after routine stability testing determined that those lots no longer met the potency specificationsanofi pasteurswiftwater, pa1/7/2010influenza a (h1n1) 2009 monovalent vaccine l

11、ive22, intranasal expiration date update expiration period than that indicated on the label.medimmunephiladelphia, pa12/22/2009influenza a (h1n1) 2009 monovalent vaccine live, intranasal1lots 500754p, 500756p, 500757p, 500758p, 500759p, 500760p, 500761p and 500762pmay expire before their labeled exp

12、iration dates and are being recalled as a precautionary measure.medimmune llcphiladelphia, pa2/4/2009fluvirin (influenza virus vaccine) luer-lok pre-filled syringes11lot numbers: 878771p, 878772p, 878773p, 878775p, 878776proutine stability testing of fluvirin in prefilled luer-lok syringes revealed

13、a minor deviation in the potency of the a/brisbane (h1n1) component of the vaccine.novartis vaccines and diagnostics limitedliverpool united kingdomexample: recalled vaccines by who date notificationbrand nameproduct descriptionreason/problemcompany15/12/2010 yellow fever vaccine lots 2148 (20-dose

14、ampoules, expiration september 2012) and 2159 (20-dose ampoules, expiration october 2012) dark brown material which was sticking to the neck of the glass ampoule institute pasteur, dakar, senegal 28/7/2010shan5 (dtwp-hepatitis b-hib)white sediment sticking to shan 5 vaccine vials that was difficult or impossible toresuspend (flocculation)sh