我国原料药生产企业执行WHO GMP的评估工具验证

发布时间：2018-03-09 15:46

本文选题：原料药生产企业　切入点：世界卫生组织药品生产管理规范　出处：《中国新药杂志》2015年06期 　论文类型：期刊论文

【摘要】：目的:为客观评估我国活性原料药(active pharmaceutical ingredients,APIs)生产企业执行WHO GMP中的能力和现状,对评估工具进行验证,考察工具的信度(可靠性)和效度(准确性)。方法:根据设定标准,筛选国内3家APIs生产企业和9名GMP专家参与验证。对于每家企业,先后应用评估工具进行自我评价和GMP专家独立评估,比较3种(严重、主要和次要)缺陷差异,考察信度。对参与评估的GMP专家进行问卷调查和访谈,评价工具对WHO GMP标准覆盖的全面性和代表性,考察效度。收集和整理企业和专家对于评估工具改进建议。结果:企业自评和专家独立评估结果均显示,3家企业均无"严重"缺陷项。在自评中,企业A,B,C的"主要"和"次要"缺陷项数量分别是(2;9),(22;36),(3;8);在独立评估中,企业A,B,C的"主要"和"次要"缺陷分别是(3;12),(26;41),(4;9)。经统计学分析,企业自评和专家独立评估结果之间没有显著差异。专家访谈显示,9名专家均认为评估工具覆盖性良好,除4名专家认为4个评估指标有重复外,其余5名专家均认为代表性良好。企业和专家提出建议,对于指标重复、规定过细、缺乏操作性的情况进行改进。结论:经适宜企业和专家参与验证,认为该评估工具具有良好的信度和效度,能够测评我国APIs企业执行WHO GMP标准的差距和进度,在进行适当调整和完善后,可以在国内推广使用。
[Abstract]:Objective: to evaluate objectively the ability and present situation of active pharmaceutical products (API) manufacturing enterprises in China to implement WHO GMP, to verify the evaluation tools, and to investigate the reliability (reliability) and validity (accuracy) of the tools. Methods: according to the set standards, Three domestic APIs production enterprises and nine GMP experts were selected to participate in the verification. For each enterprise, self-evaluation and independent evaluation by GMP experts were carried out successively, and the differences of three (serious, primary and secondary) defects were compared. Questionnaire survey and interview with GMP experts who participated in the evaluation, and the comprehensive and representative coverage of WHO GMP standard by evaluation tools. Check the validity. Collect and collate the suggestions of enterprises and experts for the improvement of evaluation tools. Results: the results of self-assessment and independent expert evaluation show that there are no "serious" defects in all three enterprises. The number of "main" and "minor" defects in AHBHU C of enterprises are respectively 2 / 2 / 2 / 2 / 3 / 36 / 1 / 3 / 80.In independent assessment, the "main" and "secondary" defects of AZB / C in enterprises are respectively 31D / 41D / 491. According to statistical analysis, the number of "main" and "minor" defects of AHBHU C in enterprises is 41D / 41.The number of "main" and "minor" defects of AHBHOC is 41nil / 41. There was no significant difference between the results of self-assessment and independent evaluation of experts. The interviews of experts showed that all nine experts considered the coverage of the evaluation tools to be good, except that four experts thought that the four evaluation indicators were duplicated. The remaining five experts were all considered to be well represented. Enterprises and experts made suggestions to improve the situation in which indicators were duplicated, the rules were too detailed, and there was no operation. Conclusion: after the participation of the appropriate enterprises and experts, It is concluded that the evaluation tool has good reliability and validity, and can evaluate the gap and progress of implementing WHO GMP standard in APIs enterprises in China. After proper adjustment and improvement, it can be popularized and used in China.
【作者单位】：沈阳药科大学;中国食品药品检定研究院;中国医药质量管理协会;
【基金】：Bill and Melinda Gates Foundation(Global Health Grant Number OPPGH5258)
【分类号】：R95

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