生物技术良好实验室实践的原则:作为知识转移创新模式的多标准决策辅助

IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Accreditation and Quality Assurance Pub Date : 2023-07-24 DOI:10.1007/s00769-023-01546-x
Elisa Rosa dos Santos, Evaldo Cesar Cavalcante Rodrigues, José Mauro Granjeiro
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引用次数: 0

摘要

生物技术政策鼓励建立开展生物测定和临床前研究的机构网络,并鼓励实施良好实验室实践原则。然而,对于经过培训和合格的专业人员来说,理解、制定程序和文件,并正确实施质量管理要求,以实施实验室质量体系,这一点变得至关重要。多标准决策辅助(MCDA)等工具的使用可以帮助管理和实施机构和实验室的质量体系。本研究旨在证明受访者对理解GLP原则的困难程度的感知,并通过MCDA模型进行分析。根据MCDA方法,对来自实验室的27名专业人员进行了一项调查,他们回答了一份问卷,问卷的数字量表为非常困难、困难、常规、中性和容易,适用于每个GLP要求。结果证明了GLP标准需要更小和更大的努力才能被理解,并允许确定努力水平以提高每个GLP标准的理解水平。MCDA被证实是一个强大的工具,可以识别和验证参与者对GLP标准的看法,考虑到专业人员的多样性和他们的不同资质,从而能够构建考虑每个标准难度水平的培训内容。这一策略有助于实验室的管理,并向生物技术专业人员、学者和学生传播GLP原理的知识。
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The principles of good laboratory practices in biotechnology: multicriteria decision aid (MCDA) as an innovative model for transferring knowledge

The biotechnology policy encourages the creation of networks of institutions that carry out bioassays and preclinical studies and stimulate the implementation of principles of good laboratory practice (GLP). However, it becomes essential for trained and qualified professionals to understand, develop procedures and documents, and properly implement quality management requirements to implement a laboratory quality system. The use of tools such as multicriteria decision aid (MCDA) can assist in managing and implementing the quality system in institutions and laboratories. This research aimed to demonstrate the perception of the degree of difficulty in understanding GLP principles perceived by the respondents and analyzed through the MCDA model. According to the MCDA method, a survey was carried out with 27 professionals from laboratories who answered a questionnaire with a numerical scale of very difficult, difficult, regular, neutral, and easy for each GLP requirement. Results evidenced the GLP criteria that require a smaller and greater effort to be understood and allowed the identification of efforts level to increase each GLP criteria's level of understanding. The MCDA confirms to be a robust tool to identify and validate the participants' perception of GLP criteria, considering the diversity of professionals and their different qualifications, enabling the construction of training content that considers the difficulty levels of each criterion. This strategy helps in the management of the laboratory and the dissemination of knowledge of GLP principles to biotechnology professionals, academics, and students.

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来源期刊
Accreditation and Quality Assurance
Accreditation and Quality Assurance 工程技术-分析化学
CiteScore
1.80
自引率
22.20%
发文量
39
审稿时长
6-12 weeks
期刊介绍: Accreditation and Quality Assurance has established itself as the leading information and discussion forum for all aspects relevant to quality, transparency and reliability of measurement results in chemical and biological sciences. The journal serves the information needs of researchers, practitioners and decision makers dealing with quality assurance and quality management, including the development and application of metrological principles and concepts such as traceability or measurement uncertainty in the following fields: environment, nutrition, consumer protection, geology, metallurgy, pharmacy, forensics, clinical chemistry and laboratory medicine, and microbiology.
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