Concept of process capability indices as a tool for process performance measures and its pharmaceutical application
Concept of process capability indices as a tool for process performance measures and its pharmaceutical application
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过程能力指数的概念作为过程性能测量的工具及其制药应用
DOI：
10.22270/jddt.v10i5.4288
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发表时间：
2020
期刊：
影响因子：
--
通讯作者：
I. Padhy
中科院分区：
文献类型：
--
作者：
A. P. Mahapatra;Jianwu Song;Zhibo Shao;Tang Dong;Zihong Gong;Basudev Paul;I. Padhy
本研究的主要目的是提出过程能力的概念，并强调其在制药工业中的意义。从实际的观点来看，当考虑工厂或供应基地的数百个特性时，控制图（如X和R哈特）有时并不方便进行汇总统计。在许多情况下，能力指数可用于关联过程参数。由此产生的指数是无单位的，并提供了一个共同的，易于理解的语言量化的过程的性能。过程能力指数（PCI）是研究制造满足规格的产品的过程能力的有力手段。Cp、Cpu、Cpl和Cpk等几种能力指标已广泛应用于制造业，以提供对过程潜力和性能的通用定量衡量标准。这些指标的计算公式易于理解，并可直接实现。过程能力分析将受控过程的输出分布与其规格限值进行比较，以确定符合规格的一致性。过程能力在制药工业中也发挥着重要作用。工艺能力指数是确保制剂质量和工艺稳健性的有力工具。确定过程能力比简单地计算每年通过或失败的批次百分比更能洞察任何制药过程性能。
The main objective of the present study is to present the concept of process capability and to focus its significance in phar maceutical industries. From a practical view point, the control charts (such as X and R hart) sometimes are not convenient summary statistics when hundreds of characteristics in a plant or supply base are considered. In many situations, capability indices can be used to relate the process parameters. The resulting indices are unit less and provide a common, easily understood language for quantifying the performance of a process. Process capability indices (PCIs) are powerful means of studying the process ability for manufacturing a product that meets specifications. Several capability indices including Cp, Cpu, Cpl and Cpk have been widely used in manufacturing industry to provide common quantitative measures on process potential and performance. The formulas for these indices are easily understood and can be directly implemented. A process capability analysis compares the distribution of output from an in-control process to its specifications limits to determine the consistency with which the specifications can be met. The process capability is also having a significant role in pharmaceutical industry. Process capability indices can be a powerful tool by which to ensure drug product quality and process robustness. Determining process capability provides far more insight into any pharmaceutical process performance than simply computing the percentage of batches that pass or fail each year.