發(fā)布時(shí)間：2018-05-11 22:15

  本文選題：口服固體制劑生產(chǎn)企業(yè) + 世界衛(wèi)生組織良好的藥品生產(chǎn)規(guī)范　； 參考：《中國(guó)新藥雜志》2015年03期

【摘要】：目的:為客觀評(píng)估我國(guó)口服固體制劑(oral solid dosage preparations,OSDP)生產(chǎn)企業(yè)執(zhí)行WHO GMP的能力和現(xiàn)狀,WHO開(kāi)發(fā)了一套評(píng)估工具,它由17個(gè)大項(xiàng)、48個(gè)小項(xiàng)指標(biāo)構(gòu)成。在推廣使用前,需要對(duì)工具進(jìn)行驗(yàn)證,考察評(píng)估工具的信度(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(guó)內(nèi)3家OSDP生產(chǎn)企業(yè)和9名GMP專家參與驗(yàn)證。對(duì)于每家企業(yè),先后應(yīng)用評(píng)估工具進(jìn)行自我評(píng)價(jià)和GMP專家獨(dú)立評(píng)估,比較3種(嚴(yán)重、主要和次要)缺陷差異,考察信度。對(duì)參與評(píng)估的GMP專家進(jìn)行問(wèn)卷調(diào)查和訪談,評(píng)價(jià)工具對(duì)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(duì)于評(píng)估工具改進(jìn)建議。結(jié)果:企業(yè)自評(píng)和專家獨(dú)立評(píng)估結(jié)果均顯示,3家企業(yè)均無(wú)"嚴(yán)重"缺陷項(xiàng)。在自評(píng)中,企業(yè)A,B,C的"主要"和"次要"缺陷項(xiàng)數(shù)量分別是(4,16)、(6,18)、(6,17);在獨(dú)立評(píng)估中,企業(yè)A,B,C的"主要"和"次要"缺陷分別是(5,17)、(5,21)、(8,18)。經(jīng)統(tǒng)計(jì)學(xué)分析,企業(yè)自評(píng)和專家獨(dú)立評(píng)估結(jié)果之間沒(méi)有顯著差異。專家訪談顯示,9名專家均認(rèn)為評(píng)估工具覆蓋性良好,除3名專家認(rèn)為3個(gè)評(píng)估指標(biāo)有重復(fù)外,其余6名專家均認(rèn)為代表性良好。結(jié)論:經(jīng)適宜企業(yè)和專家參與驗(yàn)證,認(rèn)為該評(píng)估工具具有良好的信度和效度,能夠測(cè)評(píng)我國(guó)OSDP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,可以用于在國(guó)內(nèi)推廣使用。
[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.
【作者單位】： 沈陽(yáng)藥科大學(xué);中國(guó)食品藥品檢定研究院;中國(guó)醫(yī)藥質(zhì)量管理協(xié)會(huì);
【基金】：Bill and Melinda Gates Foundation資助(Global Health Grant Number OPPGH5258)
【分類號(hào)】：F426.72

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