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相关概念视频

Design Consideration01:22

Design Consideration

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Designing a structure involves a series of considerations, primarily the material's ultimate strength, calculated through tests that measure changes under increased force until the material reaches its breaking point or limit. The ultimate load, where the material breaks, is divided by its original cross-sectional area, resulting in the ultimate normal stress or strength. The ultimate shearing stress is another significant factor taken into account.
The factor of safety is another key...
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Quality Control01:05

Quality Control

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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
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Yield Criteria for Ductile Materials under Plane Stress01:25

Yield Criteria for Ductile Materials under Plane Stress

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In designing structural elements and machine parts using ductile materials, it is crucial to ensure that these components withstand applied stresses without yielding. Yielding is initially determined through a tensile test, which evaluates the material's response to uniaxial stress. However, tensile stress is insufficient when components face biaxial or plane stress conditions This condition requires advanced criteria to predict failure.
The Maximum Shearing Stress Criterion, also known as...
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Quality Assurance01:19

Quality Assurance

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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Cleaning, Sterilization, and Disinfection01:30

Cleaning, Sterilization, and Disinfection

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Cleaning, disinfection, and sterilization are the methods that help to break the infection chain and prevent disease.
Cleaning
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Critical Thinking II01:25

Critical Thinking II

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Critical thinking is a cognitive process with several attributes. The attributes of critical thinking include the following:
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在资格关键供应商的考虑因素.

Amy Summers1

  • 1Restore Health Consulting LLC, Laguna Beach, California. info@restorehealthconsulting.com.

International journal of pharmaceutical compounding
|December 15, 2023
PubMed
概括

新的美国药典 (USP) 标准要求化合物制造商从FDA注册的设施获得活性药物成分和辅助剂. 药房现在必须实施强有力的供应商资格认证流程,以确保质量和合规性.

科学领域:

  • 制药复合剂 制药复合剂
  • 监管合规性 监管合规性
  • 质量保证 质量保证 质量保证

背景情况:

  • 即将到来的美国药典 (USP) <797>和 <795> 修订要求在FDA注册的设施采购活性药物成分 (API) 和辅助剂.
  • 美国食品和药物管理局 (FDA) 建议化合物制造商对其批量API和辅助剂供应商进行审查.
  • 监管机构越来越多地要求503A复合药房展示供应商资格程序,反映503B外包设施的要求.

研究的目的:

  • 指导药店建立和实施有效的供应商资格认证计划.
  • 确保关键的供应和服务符合质量和合规规范.
  • 为不断变化的监管期望准备复合者,以适应有关供应商监管的不断变化的监管期望.

主要方法:

  • 对即将发布的USP<797>和<795>指导方针进行审查.
  • 分析FDA对供应商知识的建议.
  • 讨论应用于供应商资格的质量保证原则.
  • 审查监管和认证机构对503A组合物的期望.

主要成果:

  • 药房需要主动开发并将供应商资格纳入其质量保证框架.
  • 了解和审查供应商对于遵守新的USP标准至关重要.

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  • 展示对供应商资格的系统方法正在成为标准期望.
  • 结论:

    • 实施全面的供应商资格计划对于药房来说至关重要,以满足新的监管需求.
    • 积极的供应商管理可以提高复合药品的质量和安全性.
    • 采用这些做法可以确保合规性,并加强整体质量保证计划.