药品质量控制实验室电子天平期间核查和日常核查管理方法探讨

目的:电子天平的期间核查和日常核查均为保证实验室量值溯源有效性的重要组成部分,是药品质量控制实验室保证检测结果准确性的有效手段.研究希望通过实施方法的介绍,为药品质量控制实验室电子天平期间核查和日常核查的展开提供借鉴.方法:通过对电子天平工作原理的认识,梳理使用和核查时的注意事项和相关参数,并根据本实验室的实践经验,介...     

关于药品检验机构期间核查问题的探讨

目的阐述期间核查对药品检验机构的意义,解释期间核查定义、目的,探讨期间核查的方法。方法分析如何选择期间核查对象、期间核查方法以及期间核查结果判定依据等。结果和结论 对于药检实验室,期间核查工作是一项日常重要的质量管理工作,需要管理部门和实验室专业技术人员互相配合,严格按照期间核查计划和相关管理程序及作业指导书操作,才能取得良好的效果。     

基层药品检验所仪器期间核查方法研究

目的探讨基层药品检验所如何有效地开展仪器期间核查的相关问题。方法参阅相关文献中介绍的期间核查方法,结合基层药品检验所的现状、工作的特点及核查过程中存在的问题进行核查。结果与结论提出了可供基层药品检验所参考的期间核查方法,即主要从对象的选择、标准的选择、参数的选择、方法的选择及结果分析等方面入手进行核查。为实验室运行管理中更加科学合理、简单高效地开展这项工作奠定了基础。     

中药对照药材的稳定性及期间核查

目的：为保证中药对照药材的质量稳定和质量可追溯性,使其在国家食品药品监管工作中切实有效地发挥技术支持作用,探讨研究中药对照药材稳定性期间核查的方法及方法的可行性。方法：介绍中药对照药材的特性及影响中药对照药材质量稳定性的主要因素,依据中国合格评定国家认可委员会（CNAS）发布的CNAS-CL01（即ISO/IEC 17025：2005）《检验和校准实验室能力认可准则》、《国家药品标准物质管理办法》,建立基于薄层色谱鉴别方法的稳定性期间核查技术方案及评价方法。结果：核查方案及评价方法取得了良好的稳定性评价结果,能够发现并及时处理相关问题,提高了中药对照药材的研制效率。结论：稳定性期间核查工作,是保证中药对照药材质量的重要措施。新建立的核查方法操作简捷,行之有效。     

国家药品标准物质稳定性核查探讨

目的:阐述药品标准物质的稳定性核查在药品检验及质量控制中的作用,解释药品标准物质稳定性核查定义、探讨稳定性核查的方法.方法:分析如何选择稳定性核查对象、稳定性核查方法及稳定性核查结果判定依据等.结果:根据GB/T 27025-2008/ISO/IEC 17025:2005<检测和校准实验室能力的通用要求>,实施药品标准物质的稳定性核查,确保国家药品标准物质的量值准确.结论:定期进行国家药品标准物质特性量值的稳定性核查,是保证其量值准确性的重要措施.     

试论国家药品标准物质的稳定性及期间核查

目的 为做好国家药品标准物质期间核查工作提供参考.方法 介绍了国家对标准物质期间核查的基本要求及国家药品标准物质的稳定性核查工作,详细论述了稳定性的定义、影响药品标准物质稳定性的因素、保证药品标准物质稳定性的措施以及药品标准物质稳定性核查工作的原则、核查品种、核查间隔、核查项目、核查方法及核查结果评价等内容.结果与结论 国家药品标准物质是药品质量分析中使用的实物对照,也是药品检验不可缺少的物质.中国食品药品检定研究院将进一步加强药品标准物质的稳定性核查工作,以确保药品标准物质的有效性.     

利用期间核查确认药品标准物质特性量值溯源性

目的探讨期间核查在保证药品标准物质特性量值溯源性中的作用。方法根据药品标准物质研制的特点,找出研制过程中可能影响标准物质特性量值溯源有效性的关键因素,参照ISO/IEC 17025：2005《检测和校准实验室能力的通用要求》确定其中需要进行期间核查的对象,并选择适宜的核查参数和与其相适宜的结果判定依据。结果与结论通过期间核查的方式,可以确认药品标准物质研制过程中整个溯源体系的有效性。     

药品检测实验室标准物质的管理、使用和期间核查

《实验室资质认定评审准则》中对实验室使用的标准物质有明确的要求,标准物质在实验室内部和实验室之间的质量控制、质量保证及技术仲裁等工作中起着传递量值的标尺作用。本文从标准物质的管理、使用和期间核查等方面综述如何切实有效地做好药品检测实验室标准物质的全面管理。     

基层疾控机构理化实验室期间核查方法与探讨

为保证检测数据公正、准确和可靠,有必要采用有效的质量控制手段确保实验室各检测环节均处于有效的控制状态,期间核查是维持仪器检定或校准状态的可靠性的重要工作。基于基层疾控机构理化实验室的现状及其存在的发展问题,对基层理化实验室如何有效开展仪器期间核查进行探讨,提出可供基层理化实验室参考的期间核查方法。     

食品药品检测机构仪器设备期间核查管理探讨

目的：总结食品药品检测机构期间核查存在的问题,提出仪器设备期间核查的管理方法。方法：统计4种常用设备2011-2015年的期间核查数据,对非正常使用情况进行分析,提出从核查方法、核查组织和核查结果等方面对期间核查进行管理。结果：2011-2015年,仪器设备的正常使用率为89.1%,根据设备使用年限及时调整了期间核查周期。结论：期间核查是保证仪器设备状态正常的重要手段。     

Combining ISO/IEC 17025:2005 and European Commission Decision 2002/657 audit requirements: a practical way forward

Laboratories involved in the analyses of veterinary drug residues are under increasing pressure to demonstrate that they produce meaningful and reliable data. Quality assurance and quality control systems are implemented in laboratories to provide evidence of this and these are subject to external assessment to ensure that they are effective. Audits to ISO/IEC 17025:2005, an internationally accepted standard, and subsequent accreditation provide laboratories and their customers with a degree of assurance that the laboratories are operating in control and the data they report can be relied on. However, national or regional authorities may place additional requirements on laboratories to ensure quality data are reported. For example, in the European Union, all official control laboratories involved in veterinary drug residue analyses must also meet the requirements of European Commission Decision 2002/657/EC which sets performance criteria for analytical methods used in this area and these are subject to additional audits by national or regional authorities. All audits place considerable time and resource demands on laboratories and this paper discusses the burden audits place on laboratories and describes a UK initiative to combine these audits to the benefit of both the regulatory authority and the laboratory.     

超声诊断在居民健康检查与健康干预中的分析

目的讨论超声诊断在居民健康检查与干预中的临床运用价值。方法选择2011年4月至2012年3月在我院进行健康检查者8796例,通过统计超声检查结果,分析超声诊断在健康检查与干预中的价值。结果经过检查,共发现7类疾病,患病人数976例,患病率为11.1%。疾病的发生与年龄有密切的关系,31~50岁人群更容易出现各类疾病。结论超声诊断在健康体检中有着重要的临床价值。对于31~50岁年龄段,有必要定期进行健康检查。     

A survey of hospitals with computerized incorporation of the pharmacy patient profile and medication administration record.

A survey was distributed in 1985 to 48 hospitals throughout the United States known to have a single-source computer-generated pharmacy patient profile and medication administration record. The study centered on staff attitude toward this single source concept, time and staff requirements when compared to traditional methods of record keeping, and how up-to-the-minute information is disseminated between pharmacy and nursing. A major issue of consideration is the ability of such a system to maintain a method of checks and balances as far as reference to and interpretation of physicians' orders. The investigation revealed that 85% of the respondents felt that the checks and balances remains intact even though one party, nursing or pharmacy, is responsible for data entry that is used by both departments during the medication cycle. More than 88% of the returned surveys included a recommendation that such systems be adopted. Increased efficiency, maintainence of accuracy, and less time spent in dealing with discrepancies when compared with the duplicative manual process of order transcribing and profiling make transition to computerization an acceptable alternative. The information provided is subjective.     

实验大鼠细小病毒 H-1株抗体检测能力验证结果评价

目的：了解全国实验动物检测相关实验室在大鼠细小病毒 H-1株抗体检测项目的技术水平,发现并解决检验中存在的问题,促进各实验室加强质量管理,提高检测水平。方法不限定检测方法,推荐各参加实验室参照国标规定的方法,对统一发放的大鼠血清样品进行细小病毒 H-1株的定性检测,结果以阳性或阴性表示,与预期结果均一致判为满意结果,不完全一致或逾期未反馈结果判为不满意。结果来自13个省市自治区的18家单位报名参加本次比对实验,1家单位因故退出,实际参加并发放比对样品共17家单位,其中16家在规定时间反馈了检测结果,1家未在规定时间反馈结果,反馈结果的16个实验室检测结果均为满意,占参加比对实验室的94%,其中13个实验室使用外购试剂盒,14个实验室采用酶联免疫吸附法（ELISA）检测,仅2个实验室对阳性结果进行了复检。结论全国各实验动物检测机构大鼠细小病毒 H-1株总体检测能力较高,个别实验室因故未参加或逾期未反馈结果,检测能力有待考察。     

Going paperless: implementing an electronic laboratory notebook in a bioanalytical laboratory

AIT Bioscience, a bioanalytical CRO, implemented a highly configurable, Oracle-based electronic laboratory notebook (ELN) from IDBS called E-WorkBook Suite (EWBS). This ELN provides a high degree of connectivity with other databases, including Watson LIMS. Significant planning and training, along with considerable design effort and template validation for dozens of laboratory workflows were required prior to EWBS being viable for either R&D or regulated work. Once implemented, EWBS greatly reduced the need for traditional quality review upon experiment completion. Numerous real-time error checks occur automatically when conducting EWBS experiments, preventing the majority of laboratory errors by pointing them out while there is still time to correct any issues. Auditing and reviewing EWBS data are very efficient, because all data are forever securely (and even remotely) accessible, provided a reviewer has appropriate credentials. Use of EWBS significantly increases both data quality and laboratory efficiency.     

The application of information technology to regional,national, and global surveillance of antimicrobial resistance

Establishing local, national, and global surveillance networks for monitoring the dissemination of antimicrobial resistance and detecting the emergence of new resistance mechanisms has been recommended by the American Society for Microbiology Task Force on Antibiotic Resistance and other national organizations. While the need to develop and deploy surveillance strategies cannot be argued, the design and implementation of effective regional, national, and global surveillance networks is a daunting task with geographic, participatory, logistic, and funding challenges. Using information technology to capture, combine, collate, and analyze daily clinical microbiology laboratory data would seem to be a far more robust and logical approach to surveillance than traditional centralized studies that generally focus on only a few bacterial species or on isolates from a single body site. Information technology allows long-term, continuous tracking of antimicrobial resistance trends among large numbers of isolates over a broad range of species, and across entire regions or countries. The rationale for wanting to use networks of clinical laboratories for surveillance is obvious: susceptibility data are generated every day by thousands of laboratories located around the world, and most of these laboratories perform antimicrobial susceptibility testing on the bacterial species that pose the greatest public health problems. By virtue of information technology, large volumes of data can readily be managed and stored to allow timely and thorough analysis on institutional, regional, national, and global levels.     

Covariance analysis of laboratory variance in steady-state serum phenytoin concentrations

Inpatients (n = 57) on long term prophylaxis with 2 oral phenytoin preparations were followed up via monthly checks of serum drug concentrations. Duplicate serum aliquots were submitted to 2 laboratories, and covariance analysis was used to estimate laboratory error. The laboratory-associated variance of examinations using the 'EMIT' or 'TDX' systems was 7.1 to 10 (mg/L)2, while that of chromatographic assays was 37.1 (mg/L)2. Laboratory errors were distributed in a non-normal fashion. The ratio of the maximum rate of metabolism (Vmax) and the Michaelis-Menten constant (Km) tended to remain constant between individuals. A linear analytical model showed little more residual variance than one based on Michaelis-Menten pharmacokinetics.     

探析实验室认可对药品检测领域授权签字人的要求

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。