我国口服固体制剂生产企业执行WHO GMP的评估工具验证

发布时间：2018-05-11 22:15

本文选题：口服固体制剂生产企业 + 世界卫生组织良好的药品生产规范　；参考：《中国新药杂志》2015年03期

【摘要】：目的:为客观评估我国口服固体制剂(oral solid dosage preparations,OSDP)生产企业执行WHO GMP的能力和现状,WHO开发了一套评估工具,它由17个大项、48个小项指标构成。在推广使用前,需要对工具进行验证,考察评估工具的信度(可靠性)和效度(准确性)。方法:根据设定标准,筛选国内3家OSDP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(4,16)、(6,18)、(6,17);在独立评估中,企业A,B,C的"主要"和"次要"缺陷分别是(5,17)、(5,21)、(8,18)。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3名专家认为3个评估指标有重复外,其余6名专家均认为代表性良好。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OSDP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,可以用于在国内推广使用。
[Abstract]:Objective: to evaluate objectively the ability and present situation of oral solid dosage preparations for the implementation of WHO GMP in Chinese production enterprises, a set of evaluation tools has been developed, which consists of 17 large items and 48 minor indexes. Before popularizing the tool, it is necessary to verify the tool and evaluate the reliability (reliability) and validity (accuracy) of the evaluation tool. Methods: according to the established criteria, 3 OSDP manufacturers and 9 GMP experts were selected to participate in the validation. For each enterprise, self-evaluation and independent evaluation by GMP experts were carried out successively. The differences of three (severe, primary and secondary) defects were compared, and reliability was investigated. Questionnaires and interviews were conducted among GMP experts who participated in the evaluation. The comprehensive and representative coverage of the WHO GMP standards was evaluated by the evaluation tools and the validity was investigated. Collect and collate suggestions from companies and experts on how to improve evaluation tools. Results: the results of self-assessment and expert independent evaluation showed that there were no serious defects in 3 enterprises. In the self-assessment, the number of "main" and "secondary" defects of AZB / C were 416 / 618 / 617 / 617 respectively. In independent assessment, the "main" and "secondary" defects of AHB / C were 517 / 521 / 818 / 518 respectively. By statistical analysis, there is no significant difference between the results of self-evaluation and independent evaluation of experts. The expert interviews showed that all 9 experts considered the coverage of the evaluation tools to be good, except for 3 experts who thought that the three evaluation indicators were duplicated, the other 6 experts considered that the evaluation tools were well representative. Conclusion: the evaluation tool has good reliability and validity, and can evaluate the gap and progress of implementing WHO GMP standard in OSDP enterprises of our country, after the appropriate adjustment and improvement, the evaluation tool is verified by the participation of suitable enterprises and experts. Can be used to promote the use in the country.
【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资助(Global Health Grant Number OPPGH5258)
【分类号】：F426.72

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