过程能力分析用于药品质量管理实证研究

目的 建立基于过程能力分析的药品质量管理体系。方法 阐述过程能力分析理论和应用模型,通过实证研究分析其在药品领域的应用价值。结果 建立基于过程能力分析的药品质量管理体系,总结药品生产企业进行过程能力分析评价的基本程序,明确过程能力分析在药品质量领域的实践意义。结论 过程能力分析在药品全过程质量管理体系中发挥评估和控制作用,可有针对性地解决问题,提升药品质量。     

近红外光谱分析技术在制药领域中的应用研究进展

目的对近红外光谱分析技术在制药领域中的应用进行综述,为药品生产过程质量控制与优化提供参考。方法查阅国内外近年来文献,进行归纳总结。结果与结论近红外光谱分析技术作为一种有力过程分析工具,对于提高药品生产效率,强化对药品的质量控制具有重要意义,随着研究的深入,近红外光谱分析技术将在制药领域发挥更深刻的作用。     

Minitab软件在药品生产质量控制中的应用

目的:探讨药品生产过程的质量控制方法。方法:以甲硝唑芬布芬胶囊为例,收集胶囊充填时的装量数据,运用Minitab软件制作质量控制图,监控制造过程,评价过程能力。结果:及时发现了看似稳定的生产过程中的异常,装量均在内控标准范围内,但已呈现不良趋势,且过程能力指数值较低(CPK=0.78);进行在线改进后,过程标准差显著降低(P<0.05),过程能力值增加(CPK=0.90);持续改进后,过程能力指数明显提高(CPK=1.12)。结论:基于Minitab的质量控制图及过程能力分析是提高药品生产稳定性、保证药品质量的较好方法。     

统计过程控制(SPC)在药品生产质量管理中的运用

目的是概述统计过程控制及控制图的原理、过程能力评估的原则。方法选择了实际工作中常规控制图的制作、过程能力指数计算的应用。结果期望能引导常规控制图在药品生产质量管理中正确运用。结论产品质量具有变异性且有统计规律。     

药品费用影响因素的指数分析方法

为分析药品费用不断上涨的结构性原因,本文回顾了国内外药品费用影响因素研究进展,并详细介绍了药品费用指数分析方法历史发展过程中的3个重要阶段——二因素、三因素及六因素指数计算及分析方法,并对其优缺点和适用条件进行逐一评析,以期为药品费用实证研究者提供方法学启示。     

有关装量差异验证方法的讨论

在药品生产的过程中,装量差异是一个关键的中间控制指标,通过利用工序能力指数的方法进行装量差异的分析,提供工序能力指数方法可行性的分析,利用科学有效且便捷的方式以取代传统的验证方式.     

数据挖掘技术在药品不良反应监测领域中的应用

目的:探讨数据挖掘技术在药品不良反应(ADR)监测领域中的应用,为中国ADR监测领域探索新方法提供参考。方法:以"数据挖掘""药品不良反应""电子医疗记录""医院信息系统"等关键词检索中国知网、万方数据、Pub Med等数据库相关文献,对数据挖掘在自发呈报系统和电子医疗记录ADR监测领域中的应用现状、常用方法及优缺点进行综述。结果与结论:数据挖掘技术在自发呈报系统和电子医疗记录中均能够有效发现ADR信号,具有优秀的数据分析和发掘规律的能力,在ADR监测领域将发挥重要作用。     

药品和器械行业应用经济学评价的异同

目的：分析评述经济学评价技术在药品和医疗器械行业应用的异同，解释了经济学评价在器械领域的应用较少的原因。方法：从适应症、证据链、数据可得性、商业模式等6个方面，对两者的差异进行分析。结论：经济学评价在医疗器械领域中的应用，难于在药品领域的应用，但值得开展探索。     

基层药品监管数字化和实施路径的实践与思考

数字化手段在完善政务服务、药品监管等领域已被广泛运用。借助数字化手段,可在药品研发、生产、流通、使用等多个环节完善药品监管与服务体系,满足公众持续增长的药品安全性和可及性需求,对于保障公众生命和健康具有重要意义。本文以合肥市为分析对象,对其基层药品监管数字化和实施路径、创新实践与典型应用以及存在不足进行探讨、分析和展望,以期为基层市场监管部门加强药品安全智慧监管提供借鉴和参考。     

控制图在药品质量管理中的应用

目的控制图是一种质量管理的方法,通过对生产过程的关键质量特性值进行测定、记录、评估、监测,以判断生产过程是否处于受控状态。本文分析控制图在药品质量管理中的应用,拟帮助药品生产企业更好地将控制图应用到实际的生产过程质量控制中。方法通过文献资料研究,简介控制图相关的概念及控制图的原理,结合部分实例阐述控制图的绘制过程及其在药品质量管理过程中的应用。结果与结论通过建立控制图,对平均图或极差图中任何失控状态的信号作出反应并采取及时行动,是保障药品生产质量的安全、均一、稳定的措施。     

The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis

During the development of a pharmaceutical chemical process, it is vital to establish a control strategy that will ensure the process performance and fitness for use of the active pharmaceutical ingredient (API), which in turn is essential to the drug product performance and its fitness for use. As part of the control strategy, it is very important to understand and establish critical elements of the process, one of which is the establishment of the critical process parameters that impact the critical quality attributes (CQAs) of the API. In this paper, we are proposing a method for determining the criticality of a process parameter and whether it should be listed in the common technical document as critical. By using routine process control capability across a variety of operating conditions and equipment configurations, a risk-based approach is used to identify parameters that could have a potential of impacting the CQAs of the API. Beyond establishing criticality, and understanding the operational variability, the knowledge gathered from these approaches can also be used to facilitate the efficient mapping of a multivariate design space.     

能力六合图在医院制剂硫酸镁口服溶液质量分析中的应用

目的 应用能力六合图对医院制剂硫酸镁口服溶液进行质量分析.方法 运用Minitab软件中能力分析的"六合图"功能,以硫酸镁口服溶液的硫酸镁含量为指标,判断生产过程中硫酸镁含量是否达到控制状态,硫酸镁口服溶液的生产工艺是否稳定.结果 硫酸镁含量及硫酸镁口服溶液的生产工艺处于受控状态,但存在潜在缺点.基于风险管理理念,应用...     

Bayesian assurance and sample size determination in the process validation life-cycle

Validation of pharmaceutical manufacturing processes is a regulatory requirement and plays a key role in the assurance of drug quality, safety, and efficacy. The FDA guidance on process validation recommends a life-cycle approach which involves process design, qualification, and verification. The European Medicines Agency makes similar recommendations. The main purpose of process validation is to establish scientific evidence that a process is capable of consistently delivering a quality product. A major challenge faced by manufacturers is the determination of the number of batches to be used for the qualification stage. In this article, we present a Bayesian assurance and sample size determination approach where prior process knowledge and data are used to determine the number of batches. An example is presented in which potency uniformity data is evaluated using a process capability metric. By using the posterior predictive distribution, we simulate qualification data and make a decision on the number of batches required for a desired level of assurance.     

院前急救护士应急能力培训对策

目的对院前急救护士应急能力进行培训,并观察分析。方法回顾2009年8月至2010年8月我院培训院前急救护士应急能力24人,将所有急救护士随机平均分为对照组和实验组,对照组采取常规院前急救理论培训,实验组采取急救基础理论和院前急救"应急能力"培训,两组在年龄、学历等方面无显著性差异,具有可比性。结果经过考核标准评定证实,实验组急救护士的专业素质明显高于对照组,两组比较具有显著意义,P<0.05。结论通过急救基础理论和院前急救"应急能力"培训,能够大大提高院前急救护士的专业素质及院前急救的护理质量,值得广泛的推广和应用。     

药品生产工艺验证的研究

参考国内外有关药品生产控制和工艺验证方面的文献,对药品生产工艺验证的基本内容进行了详细研究,对药品生产工艺验证的必要性和方法进行了讨论。笔者认为药品生产工艺验证是政策规范的需要;是制药企业保证药品质量的需要;也是制药企业降低成本的需要。认识到这一点,是政府监管部门做好监管,制药企业实施好验证的关键。     

对注射剂一致性评价的再思考

药物注射剂可分为普通(水溶性)注射剂和特殊注射剂,特殊注射剂应更重视对其体内疗效的评价;通过对已有的临床/质量数据、文献资料的系统梳理,揭示国产仿制药与参比制剂的质量/关键质量属性差异;评估国产仿制药与参比制剂疗效/安全性的一致性;并通过提高产品的工艺控制能力,保证产品质量的持续一致性,是注射剂一致性评价的基本方法;对国内独有的品种,应在明确其临床价值后再进行评价研究。     

Influence of physical factors on the accuracy of calibration models for NIR spectroscopy

The quality of pharmaceutical drugs is strongly influenced by a number of physical and chemical factors that require careful control during the production process in order to ensure that the end-product will meet the specifications. Near infrared spectroscopy has proved effective for monitoring changes in such factors and is currently the most widely used technique for controlling drug manufacturing processes. In this work, the authors determined an active pharmaceutical ingredient (API) throughout its production process. The influence of particle size, galenic form, compaction pressure and coating thickness on NIR spectra was evaluated with a view to developing effective methodologies for constructing simple, accurate calibration methods affording API quantization at different stages of a drug production process. All calibration models were constructed from data for laboratory samples alone and NIR calibration models for determining the API determination by using product weights as reference values. The proposed models were validated by application to samples obtained at three stages of a drug manufacturing process and comparison of the predicted values with HPLC reference values. The RSEP values thus obtained never exceeded 1.5%.     

生物效价检测研究进展

目的介绍生物效价的含义、检测方法及近年来在生化药物、化学药物和中药领域中的研究进展,以期为药品质量控制方法研究提供思路和借鉴。方法概述生物效价检测的基本概念,包括生物效价含义、检测方法分类及其选用标准、检测思路,重点论述了生物效价检测在生化药物、化学药物、中药领域中的应用情况。结果和讨论生物效价检测将作为一种常规的分析手段应用于药品的质量控制中,生物检测结合化学检测的模式将是药物质量控制的必由之路。     

Understanding Pharmaceutical Quality by Design

This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.