...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Therapeutic advances in drug safety. >Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance
【24h】

Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance

机译：监测药物的制造和质量：药物事实的基本任务

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal products, including older medicines such as generic medicinal products with a well-established safety profile. For the latter, the risk management plans no longer contain important risks, considered important safety concerns, on the basis that routine pharmacovigilance activity would not allow their further characterisation. Society assumes that unexpected adverse reactions causally related to pharmacological activity are very unlikely to be detected for such well-established medicines, but important risks can still occur. For these products, a change in the safety profile which is brand or source specific and usually local in nature, associated with failures with the adequate control of quality of manufacturing or distribution are important safety issues. These may be the consequence of manufacturing and pharmacovigilance quality systems that are not fully integrated over the product life cycle (e.g. inadequate control of quality defects affecting one or multiple batches; inadequate impact assessment of change/variation of manufacturing, quality control testing, storage and distribution processes; inadequate control over the distribution channels including the introduction of counterfeit or falsified products into the supply chain). Drug safety hazards caused by the above-mentioned issues have been identified with different products and formulations, from small molecules to complex molecules such as biological products extracted from animal sources, biosimilars and advanced therapy medicinal products. The various phases of the drug manufacturing and distribution of pharmaceutical products require inputs from pharmacovigilance to assess any effects of quality-related issues and to identify proportionate risk minimisation measures that often have design implications for a medicine which requires a close link between proactive vigilance and good manufacturing practice. To illustrate our argument for closer organisational integration, some examples of drug safety hazards originating from quality, manufacturing and distribution issues are discussed. Plain language summary Monitoring the manufacturing and quality of medicines: the fundamental task of pharmacovigilance Pharmacovigilance is the science relating to the collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products. The collection and assessment of adverse reactions are particularly important in the first decade after marketing authorisation of a drug as the information gathered in this period could help, for example, to identify complications from its use which were unknown before its commercialization. However, when it comes to medicines that have been on the market for a long time there is general acceptance that their safety profile is already well-established and unknown adverse reactions unlikely to occur. Nevertheless, even older medicines, such as generic drugs, can generate new risks. For these drugs a change in the safety profile could be the result of inadequate control of their quality, manufacturing and distribution systems. To overcome such an obstacle, it is necessary to fully integrate manufacturing and pharmacovigilance quality systems in the medicine life-cycle. This could help detect safety hazards and prevent the development of new complications which may arise due to the poor quality of a drug. Pharmacovigilance activities should indeed be included in all phases of the drugs’ manufacturing and distribution process, regardless of their chemical complexity to detect quality-related matters in good time and reduce the risk of safety concerns to a minimum.
机译：个人案件安全报告的收集和评估（ICSRS）对于检测未知的不良药物反应，特别是在新化学实体批准后的第一个十年中。但是，法规要求这些活动常规为所有药用产品进行，包括旧药品，如普通药用产品，具有良好的安全性。对于后者而言，风险管理计划不再包含重要风险，考虑到重要的安全问题，即常规药物检察活动不允许其进一步表征。社会假设对于这种良好的药物来说，对药理活性的任何因果不良反应非常不可能被检测到，但仍然可能发生重要的风险。对于这些产品，与具有充分控制制造或分配质量的失败有关的品牌或源自本地的安全配置文件的变化是重要的安全问题。这些可能是在产品生命周期内没有完全集成的制造和药物理解质量系统的结果（例如，对影响一种或多个批次的质量缺陷的控制不足;对制造的变化/变化的影响不足，质量控制测试，储存和分配过程;对分销渠道的控制不足，包括将假冒或伪造的产品引入供应链）。已经用不同的产品和制剂鉴定了由上述问题引起的药物安全危害，从小分子到复杂的分子，例如从动物来源，生物仿制性和晚期治疗药品中提取的生物制品。药物制造和药品分布的各个阶段都需要来自药物的投入，以评估质量相关问题的任何影响，并确定往往具有对药物的设计影响的比例风险最小化措施，这些措施需要在主动警惕和良好之间进行密切联系的药物制造实践。为了说明我们对仔细组织整合的论点，讨论了源自质量，制造和分配问题的药物安全危害的一些例子。普通语言概要监测药品的制造和质量：药物检测药物的基本任务是与药物产品收集，检测，评估，监测和预防不良反应的科学。由于在此期间收集的信息销售销售药物授权后的第一个十年内，对不良反应的收集和评估尤其重要，例如，在此期间收集的信息可以帮助，以识别其在商业化之前未知的使用情况。然而，在很长一段时间内达到市场的药物时，他们的安全性型材已经完善，并且不太可能发生未知的不良反应。然而，即使是旧药物，如通用药物，也会产生新的风险。对于这些药物，安全型材的变化可能是对其质量，制造和分配系统的控制不足的结果。为了克服这种障碍，有必要在医学生命周期中完全融合制造和药物理性质量体系。这有助于检测安全危害，并防止由于药物质量差而可能产生的新并发症的发展。药物事项的活动确实应包括在药物制造和分配过程的所有阶段，无论其化学复杂性如何，在良好的时期检测与质量相关的事项，并将安全问题的风险降至最低。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号