[关键词]
[摘要]
药物非临床安全性评价的质量保证是整个管理体系建设的关键,是项目实施与管理规范一致性的保证,也是标准操作规程(SOP)严格执行的动力。质量保证部SOP建设关系到部门人员的行为水准,意义重大。其SOP内容通常可分为7大类,并匹配有相应的检查表格等文件系统。各部分SOP应围绕质量保证(QA)检查、审查和监查的具体操作行为来撰写,简洁明了、条理清晰、行文规范,并具有可操作性。涉及的相关表格应设计合理、流程及记录完整,填写方便简单,形成对质量保证工作的有力支撑。
[Key word]
[Abstract]
Quality assurance (QA) in drug non-clinical safety evaluation is the key to the construction of quality management system, and it is the conforming assurance of project research and management system, also the power of standard operating procedures strictly enforce. The construction quality of the QA department standard operation process (SOP) and check form are related to the personnel's behavior standard for quality assurance, and of great significance. The SOP content is usually divided into personnel post construction, overview of QA procedures and facilities construction of QA procedures, project implementation of QA procedures, supplier and multiple site research QA procedures construction, QA statement, etc, and matching with the corresponding inspection form. Each part of SOP should be around QA examination, inspection, and monitoring specific behavior to write, short and concise, clear, writing code, and operable. Involving related form should be rational design, process and record is complete, fill out the convenience simple, form a strong support for the work of QA personnel.
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