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标准操作规程(SOPs):制定原因、类型、充分性、批准以及与标准的偏差和修订情况。

Standard operating procedures (SOPs): reason for, types of, adequacy, approval, and deviations from and revisions to.

作者信息

Isaman V, Thelin R

机构信息

QA Consulting and Testing, Salem, Utah 84653, USA.

出版信息

Qual Assur. 1995 Sep;4(3):167-71.

PMID:8705111
Abstract

Standard Operating Procedures (SOPs) are required in order to comply with the Good Laboratory Practice Standards (GLPS) as promulgated in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 40 CFR Part 160. Paragraph 160.81 (a) states: "A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study." Types of SOPs include administrative and personnel, analyses, substances, quality assurance and records, test system, equipment, and field related. All SOPs must be adequate in scope to describe the function in sufficient detail such that the study data are reproducible. All SOPs must be approved by a management level as described in a corporate organization chart. Signatures for SOP responsibility, authorship, and Quality Assurance review adds strength and accountability to the SOP. In the event a procedure or method is performed differently from what is stated in the SOP, an SOP deviation is necessary. As methods and procedures are improved, SOP revisions are necessary to maintain SOP adequacy and applicability. The replaced SOP is put into a historical SOP file and all copies of the replaced SOPs are destroyed.

摘要

为符合《联邦杀虫剂、杀菌剂和灭鼠剂法案》(FIFRA)40 CFR Part 160中颁布的良好实验室规范标准(GLPS),需要制定标准操作规程(SOP)。第160.81 (a)款规定:“测试机构应制定书面标准操作规程,阐述管理部门认为足以确保研究过程中所产生数据的质量和完整性的研究方法。”SOP的类型包括行政与人员、分析、物质、质量保证与记录、测试系统、设备以及与现场相关的内容。所有SOP的范围必须足够全面,以详细描述其功能,从而使研究数据具有可重复性。所有SOP必须由公司组织结构图中所述的管理层批准。SOP责任、编写和质量保证审核的签名增强了SOP的力度和问责性。如果某个程序或方法的执行方式与SOP中所述不同,则需要进行SOP偏差处理。随着方法和程序的改进,有必要对SOP进行修订,以保持SOP的充分性和适用性。被替换的SOP放入历史SOP文件中,被替换的SOP的所有副本均被销毁。

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