研究用药品召回的最新指南New Guideline for Recall of IMPs

清歌一曲月如霜

欧盟委员会DG健康与消费者发表了有关投诉，质量缺陷的新的欧盟GMP的第8和产品召回。本章进行了彻底修订。而当前只有不到两页的集中投诉，只记得，修订为6页，确定预期：
人事与组织
在处理程序和调查投诉包括可能的质量缺陷
调查与决策
根本原因分析和纠正与预防措施
产品召回和其他潜在的风险降低措施
质量风险管理机制在修改后的章节和重要的作用“的原则，应适用于质量缺陷的调查和评估，并在决策过程中涉及产品召回和其他降低风险的措施。”在出现质量缺陷的“，可能会导致产品或供应异常限制的召回”的情况下，各有关主管部门应当通知。
合资格人士（QP）谁参与了认证，为有关产品的发布将起到重要的作用。如果QP不直接负责管理投诉和质量缺陷的调查和决定应采取的措施，他（或她）“提出，正式知悉任何调查，任何降低风险的行动，并召回任何操作，及时“对于例如像处理，审查和调查投诉有关的所有行动，足够的人员和资源，应当提供。
修订后的章还详细额外要求召回研究用药品（IMPS）8.24。第二章说：“在研究用药品的情况下，所有试验地点应确定和目标的国家应当注明。在一个研究性的情况下，对于一名销售许可已经发出药品，试验用药品应与保荐人合作，将任何质量缺陷，可能会涉及到授权的药品上市许可持有人的制造商，主办单位应当实施程序蒙蔽产品的快速揭盲，在此有必要迅速召回。申办者应当保证程序公开盲品的唯一身份，只要是必要的。“




The European Commission DG Health & Consumers has published the new EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. Whereas the current one has less than two pages focussing on complaints and recall only, the revision is six pages long, defining expectations for:
Personnel and Organisation
Procedures for handling and investigating complaints including possible quality defects
Investigation and Decision Making
Root Cause Analysis and Corrective and Preventative Actions
Product Recalls and other potential risk-reducing actions
Quality Risk Management now plays an important role in the revised chapter and the "principles should be applied to the investigation and assessment of quality defects and to the decision-making process in relation to product recalls and other risk-reducing actions". In the case of a quality defect which "may result in the recall of the product or an abnormal restriction in the supply", all competent authorities concerned should be informed.
The Qualified Person (QP) who is involved in the certification for release of the concerned product will play an important role. If the QP is not directly responsible for managing complaint and quality defect investigations and for deciding the measures to be taken, he or she "should be made formally aware of any investigations, any risk-reducing actions and any recall operations, in a timely manner". For all respective actions like for example handling, reviewing and investigating complaints, sufficient personnel and resources should be made available.
The revised chapter also details additional requirements for recalling investigational medicinal products (IMPs).Chapter 8.24 says that "In the case of investigational medicinal products, all trial sites should be identified and the countries of destination should be indicated. In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product should, in cooperation with the sponsor, inform the marketing authorisation holder of any quality defect that could be related to the authorised medicinal product. The sponsor should implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall. The sponsor should ensure that the procedure discloses the identity of the blinded product only in so far as is necessary."

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