| 王岩,张庆生.探析实验室认可对药品检测领域授权签字人的要求[J].中国药事,2022,36(11):1246-1252 |
| 探析实验室认可对药品检测领域授权签字人的要求 |
| Analysis of Requirements for Authorized Signatories of Pharmaceutical Products Testing Laboratories |
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| DOI：10.16153/j.1002-7777.2022.11.006 |
| 中文关键词: 授权签字人 实验室认可 药品检测领域 认可规范 关键要素 |
| 英文关键词: authorized signatories laboratory accreditation pharmaceutical products testing fields accreditation documents essential factors |
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| 摘要点击次数: 753 |
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| 中文摘要: |
| 目的：确保药品检测领域授权签字人作为管理体系中的关键要素可以持续有效满足实验室认可要求。方法：结合药品检验检测机构自身工作特点，系统梳理全部认可规范，确定药品检测实验室可申请认可的领域范围，并对该领域内需遵循的各相关认可文件进行明确。结果与结论：依据相关认可文件中的条款规定，归纳出实验室认可对药品检测领域授权签字人应满足的通用性和专业性要求，同时，本文的另一关键之处在于明确了认可全周期内授权签字人应满足的其他方面要求，如人数设置、变更、认可文件转版产生的过渡期等相关规定。该内容可供相关药品检验检测机构在建立管理体系、申请实验室认可以及获认可后维持管理体系有效运行等环节中参考使用。 |
| 英文摘要: |
| Objective: To ensure that authorized signatories as essential factors of a management system in the drug testing area can effectively meet the requirements of laboratory accreditation. Methods: Combined with the work characteristics of drug inspection and testing institutions, all accreditation specifications were systematically sorted out to determine the scope of the field that drug testing laboratories could apply for accreditation, and the relevant accreditation documents followed in this field were clarified. Results and Conclusion: According to the items in the relevant accreditation documents, the general and professional requirements for authorized signatories approved by the laboratories in the field of pharmaceutical testing were summarized. Meanwhile, another key point of this paper was to clarify other requirements that authorized signatories should meet within the whole cycle of laboratory accreditation, such as numbers or changes of authorized signatories, an interim arising from the edition update of an accreditation document. The content could be used as a reference for pharmaceutical products testing laboratories to establish a management system, apply for laboratory accreditation, and maintain the effective operation of the management system after granted accreditation. |
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