Pharmaceutical quality system

Q3 Pharmacology, Toxicology and Pharmaceutics Iraqi Journal of Pharmaceutical Sciences Pub Date : 2014-10-27 DOI:10.4172/2329-6631.S1.009
Lothar Hartmann
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引用次数: 36

Abstract

Purpose: The concept of quality is embedded in every process that takes place in an organization. There is a general perception that while increasing quality cost also increases. This perception was challenged by Dr. Genichi Taguchi. Taguchi states that quality can be increased without increasing cost and cost can also be reduced by increasing quality (Campanella 1999). Measuring quality-related costs has been advocated as an important component of quality improvement (Moen 1998). Gryna (1988) states that quality related costs range from 10-30 percent of sales and 25-40 percent of operating expenses. Researchers have proposed several methods of quality cost estimation. Commonly used methods areQuality Costing Approach, Process Cost Approach and Quality Loss Approach (Campanella, 1999). Tsiakals (1983) used Quality Costing Approach (PAF Approach) to collect Cost of Quality in a Pharmaceutical Industry and Malchi and McGurk (2001) used alternative cost model (Schiffauerova et al, 2006).The present paper aimed atcollecting and measuring Cost of Poor Quality in a Pharmaceutical Industry on the basis of Process Cost Approach.
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药品质量体系
目的:质量的概念嵌入在组织中发生的每一个过程中。人们普遍认为,在提高质量的同时,成本也在增加。田口元一博士对这种看法提出了挑战。田口指出,质量可以在不增加成本的情况下提高,成本也可以通过提高质量来降低(Campanella 1999)。测量与质量有关的成本一直被提倡作为质量改进的一个重要组成部分(Moen 1998)。Gryna(1988)指出,质量相关成本占销售额的10- 30%,占运营费用的25- 40%。研究人员提出了几种质量成本估算方法。常用的方法有质量成本法、过程成本法和质量损失法(Campanella, 1999)。Tsiakals(1983)使用质量成本法(PAF法)收集制药行业的质量成本,Malchi和McGurk(2001)使用替代成本模型(Schiffauerova et al ., 2006)。本文以过程成本法为基础,对制药企业的不良质量成本进行了收集和计量。
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来源期刊
Iraqi Journal of Pharmaceutical Sciences
Iraqi Journal of Pharmaceutical Sciences Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
1.40
自引率
0.00%
发文量
37
审稿时长
24 weeks
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