本文選題：原料藥生產(chǎn)企業(yè)　切入點(diǎn)：世界衛(wèi)生組織藥品生產(chǎn)管理規(guī)范　出處：《中國新藥雜志》2015年06期 　論文類型：期刊論文

【摘要】：目的:為客觀評估我國活性原料藥(active pharmaceutical ingredients,APIs)生產(chǎn)企業(yè)執(zhí)行WHO GMP中的能力和現(xiàn)狀,對評估工具進(jìn)行驗(yàn)證,考察工具的信度(可靠性)和效度(準(zhǔn)確性)。方法:根據(jù)設(shè)定標(biāo)準(zhǔn),篩選國內(nèi)3家APIs生產(chǎn)企業(yè)和9名GMP專家參與驗(yàn)證。對于每家企業(yè),先后應(yīng)用評估工具進(jìn)行自我評價和GMP專家獨(dú)立評估,比較3種(嚴(yán)重、主要和次要)缺陷差異,考察信度。對參與評估的GMP專家進(jìn)行問卷調(diào)查和訪談,評價工具對WHO GMP標(biāo)準(zhǔn)覆蓋的全面性和代表性,考察效度。收集和整理企業(yè)和專家對于評估工具改進(jìn)建議。結(jié)果:企業(yè)自評和專家獨(dú)立評估結(jié)果均顯示,3家企業(yè)均無"嚴(yán)重"缺陷項(xiàng)。在自評中,企業(yè)A,B,C的"主要"和"次要"缺陷項(xiàng)數(shù)量分別是(2;9),(22;36),(3;8);在獨(dú)立評估中,企業(yè)A,B,C的"主要"和"次要"缺陷分別是(3;12),(26;41),(4;9)。經(jīng)統(tǒng)計學(xué)分析,企業(yè)自評和專家獨(dú)立評估結(jié)果之間沒有顯著差異。專家訪談顯示,9名專家均認(rèn)為評估工具覆蓋性良好,除4名專家認(rèn)為4個評估指標(biāo)有重復(fù)外,其余5名專家均認(rèn)為代表性良好。企業(yè)和專家提出建議,對于指標(biāo)重復(fù)、規(guī)定過細(xì)、缺乏操作性的情況進(jìn)行改進(jìn)。結(jié)論:經(jīng)適宜企業(yè)和專家參與驗(yàn)證,認(rèn)為該評估工具具有良好的信度和效度,能夠測評我國APIs企業(yè)執(zhí)行WHO GMP標(biāo)準(zhǔn)的差距和進(jìn)度,在進(jìn)行適當(dāng)調(diào)整和完善后,可以在國內(nèi)推廣使用。
[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.
【作者單位】： 沈陽藥科大學(xué);中國食品藥品檢定研究院;中國醫(yī)藥質(zhì)量管理協(xié)會;
【基金】：Bill and Melinda Gates Foundation(Global Health Grant Number OPPGH5258)
【分類號】：R95

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