Johnson D W
FEDESA/SmithKline Beecham, Louvain-la-Neuve, Belgium.
Dev Biol Stand. 1992;79:193-200.
Good Manufacturing Practice Guidelines have an inherent philosophy to maintain high standards and to promote uniformity within trading areas. Reaching these standards in some countries and maintaining them in others is costly. The Cost of Quality is regarded as a significant indicator of business performance. Quality costs are increasing as demands for improved accuracy and precision are made on the industry. The paper also details actual costs for validating a modern biological production facility and establishing biological quality control facilities. Bench mark quality control testing costs for a typical large and small animal vaccine are given.
良好生产规范指南有着维持高标准并促进贸易区域内一致性的内在理念。在一些国家达到这些标准并在其他国家维持这些标准成本高昂。质量成本被视为企业绩效的一项重要指标。随着对该行业提高准确性和精度的要求不断增加，质量成本也在上升。本文还详细说明了验证一座现代化生物生产设施和建立生物质量控制设施的实际成本。给出了典型的大型和小型动物疫苗的基准质量控制测试成本。
