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首页> 外文期刊>Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners >Safety and quality assurance of chemotherapeutic preparations in a hospital production unit: acceptance sampling plan and economic impact.
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Safety and quality assurance of chemotherapeutic preparations in a hospital production unit: acceptance sampling plan and economic impact.

机译：医院生产单位中化学制剂的安全和质量保证：验收抽样计划和经济影响。

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The opportunity to apply a sampling plan was evaluated. Costs were computed by a microcosting study.In 2003, a sampling plan was defined to reduce the number of chemotherapy quality controls while preserving the same level of quality. Recent qualitative and quantitative changes led us to define a second sampling plan supplemented by an economic evaluation to determine the cost and cost-savings of quality control.The study considers preparation produced during four semesters classified into three groups. The first one includes drugs produced below 200 batches a semester. Group 2, those for which the lot of preparation lots would have been rejected twice among these four semesters. Group 3, those would have been accepted (≥3 'acceptable lot'). A single sampling plan by attributes was applied to this group with an acceptance quality level of 1.65% and a lot tolerance percent defective below 5%. A micro-costing study was conducted on quality control, from the sampling to the validation of the results.Among 39 cytotoxic drugs, 11 were sampled which enabled to avoid a mean of 17,512 control assays per year. Each batch of the 28 non-sampled drugs was however analyzed. Costs were estimated at 2.98? and 5.25? for control assays depending of the analytical method. The savings from the application of the sampling plans was 153,207? in 6 years.The sampling plan allowed maintaining constancy in number of controls and the level of quality with significant costsavings, despite a substantial increase in drugs to assay and in the number of preparations produced.
机译：评估了应用抽样计划的机会。成本是通过微观成本研究计算得出的。2003年，我们制定了抽样计划，以减少化学药品质量控制的数量，同时保持相同水平的质量。最近的质和量变化促使我们定义了第二个抽样计划，并辅以经济评估来确定质量控制的成本和成本节省。研究考虑了四个学期的准备工作，分为三个组。第一个包括每学期生产200批次以下的药物。第2组，在这四个学期中，有很多准备批次被拒绝两次。第三组，那些将被接受（≥3个“可接受的批次”）。按属性的单一抽样计划应用于该组，其接受质量等级为1.65％，低于5％的大量公差百分比。从抽样到结果验证，我们对质量控制进行了微成本研究。在39种细胞毒性药物中，抽样了11种，每年平均可避免17,512次对照测定。但是，对每批28种非抽样药物进行了分析。费用估计为2.98？和5.25？根据分析方法进行对照测定。应用采样计划可节省153,207？尽管可检测的药物和制备的制剂数量大大增加，但采样计划仍可在6年内保持控制数量和质量水平的稳定，并节省大量成本。

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