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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。
OBJECTIVE: To objectively assess the capacity and status quo of WHO GMP implementation in China’s oral solid dosage preparations (OSDP) manufacturers, WHO has developed a set of assessment tools consisting of 17 large items and 48 small items. In the promotion of the use of tools need to be verified to assess the reliability of the assessment tools (reliability) and validity (accuracy). Methods: According to the set standards, three domestic OSDP manufacturers and nine GMP experts were selected for verification. For each company, self-assessment and GMP experts applied the assessment tools one after another successively to evaluate the reliability of the three kinds of (serious, major and minor) deficiencies. GMP experts involved in the assessment of the questionnaire survey and interviews to evaluate the tools covered by the WHO GMP standard comprehensiveness and representativeness, validity. Collect and organize business and expert advice on evaluating tools for improvement. Results: The results of self-assessment and expert independent assessment showed that none of the three enterprises had a “serious” defect. In the self-assessment, the number of “major” and “minor” defects in firms A, B and C are (4,16), (6,18) and (6,17) The “main” and “minor” defects of firms A, B and C are (5,17), (5,21) and (8,18), respectively. After statistical analysis, there is no significant difference between the self-assessment of enterprises and the independent assessment of experts. According to expert interviews, all nine experts considered the evaluation tools to be well-covered. All three experts considered the representative to be good, except for the three experts who considered the three evaluation indexes repeated. Conclusion: With the participation of appropriate enterprises and experts, the appraisal tool has good reliability and validity, can evaluate the disparity and progress of WHO GMP standard of OSDP in our country, and can be used in domestic market after proper adjustment and improvement Promote use.