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Managing quality risk during a pharmaceutical manufacturing facility closure.

机译：在制药厂关闭期间管理质量风险。

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摘要

Closure of individual pharmaceutical manufacturing facilities is a frequent event and often occurs over several years. Closure of a facility brings about additional quality challenges for which effective leadership, risk management, and quality planning are essential to manage. This project describes the difficulties encountered during closure including those involving human resources, facility and equipment maintenance, and quality of supplied materials, and considers them with respect to risk to product quality and potential harm to the consumer. Methods for conducting risk assessment and strategies for mitigating the risk during a time when resources are limited are discussed. The project provides examples of risk assessment and a recommended quality plan for a closing pharmaceutical facility.
机译：关闭个别药品生产设施是一个经常发生的事件，通常发生在数年之内。设施的关闭带来了额外的质量挑战，有效的领导，风险管理和质量计划对于管理是至关重要的。该项目描述了关闭过程中遇到的困难，包括涉及人力资源，设施和设备维护以及所供应材料的质量的困难，并考虑了产品质量风险和对消费者的潜在危害。讨论了在资源有限的情况下进行风险评估的方法和缓解风险的策略。该项目为关闭的制药厂提供了风险评估的示例和建议的质量计划。

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  • 作者

    Kwoka, Margaret N.;

  • 作者单位

    California State University, Dominguez Hills.;

  • 授予单位 California State University, Dominguez Hills.;
  • 学科 Engineering.;Pharmaceutical sciences.;Management.
  • 学位 M.S.
  • 年度 2015
  • 页码 98 p.
  • 总页数 98
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 现代史（1917年~）;
  • 关键词

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