Optimization of Bayesian repetitive group sampling plan for quality determination in Pharmaceutical products and related materials

IF 1.6 3区 工程技术 Q4 ENGINEERING, INDUSTRIAL
V. Kaviyarasu, Palanisamy Sivakumar
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引用次数: 2

Abstract

Sampling plans are extensively used in pharmaceutical industries to test drugs or other related materials to ensure that they are safe and consistent. A sampling plan can help to determine the quality of products, to monitor the goodness of materials and to validate the yields whether it is free from defects or not. If the manufacturing process is precisely aligned, the occurrence of defects will be an unusual occasion and will result in an excess number of zeros (no defects) during the sampling inspection. The Zero Inflated Poisson (ZIP) distribution is studied for the given scenario, which helps the management to take a precise decision about the lot and it can certainly reduce the error rate than the regular Poisson model. The Bayesian methodology is a more appropriate statistical procedure for reaching a good decision if the previous knowledge is available concerning the production process. This article proposed a new design of the Bayesian Repetitive Group Sampling plan based on Zero Inflated Poisson distribution for the quality assurance in pharmaceutical products and related materials. This plan is studied through the Gamma-Zero Inflated Poisson (G-ZIP) model to safeguard both the producer and consumer by minimizing the Average Sample Number. Necessary tables and figures are constructed for the selection of optimal plan parameters and suitable illustrations are provided that are applicable for pharmaceutical industries.
药品及相关物料质量测定中贝叶斯重复组抽样方案的优化
抽样计划在制药工业中广泛用于测试药物或其他相关材料,以确保其安全性和一致性。抽样计划有助于确定产品的质量,监测材料的优良性,并验证产品是否无缺陷。如果制造过程是精确对齐的,缺陷的发生将是一个不寻常的场合,并将导致抽样检查中多余的零(无缺陷)。研究了给定情况下的零膨胀泊松(ZIP)分布,该分布有助于管理层对批次进行精确决策,并且与常规泊松模型相比,它可以降低错误率。如果以前的知识是可用的,贝叶斯方法是一个更合适的统计程序,以达到一个好的决策。本文提出了一种新的基于零膨胀泊松分布的贝叶斯重复组抽样方案,用于药品及相关物料的质量保证。通过Gamma-Zero膨胀泊松(G-ZIP)模型对该方案进行了研究,通过最小化平均样本数来保护生产者和消费者。构造了选择最优方案参数所需的表格和图表,并提供了适用于制药工业的适当图解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.70
自引率
9.10%
发文量
35
审稿时长
20 weeks
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