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调查选定阿拉伯国家制药厂检查实践:检查员和制药业员工的看法。

Investigating inspection practices of pharmaceutical manufacturing facilities in selected Arab countries: views of inspectors and pharmaceutical industry employees.

出版信息

East Mediterr Health J. 2013 Nov;19(11):919-29.

Abstract

There are few studies that explore inspection practices of pharmaceutical facilities from the viewpoint of inspectors and industry employees. In this descriptive, cross-sectional study, inspectors and quality assurance staff from 4 Arab countries--the United Arab Emirates, Saudi Arabia, Egypt and Jordan--were surveyed about their inspection practices and views. There was considerable variation in inspection practices across countries and between the inspectorate and quality assurance staff within countries. Divergence was found in views associated with payment mechanisms. There was mutual agreement by both groups that inspectors were in short supply and that they needed to be better trained. Inspectors appeared to have less authority than expected in order to control pharmaceutical manufacturing and marketing activities. Compounding this was a dearth of policy which would support a more uniform and systematic approach to the inspection process within and across countries.

摘要

从检查员和行业员工的角度探讨制药设施检查实践的研究甚少。在这项描述性的横断面研究中,对来自 4 个阿拉伯国家(阿拉伯联合酋长国、沙特阿拉伯、埃及和约旦)的检查员和质量保证人员进行了调查,了解他们的检查做法和意见。各国之间以及各国的检查员和质量保证人员之间的检查做法存在相当大的差异。与支付机制有关的意见存在分歧。两组人员都一致认为检查员短缺,需要进行更好的培训。检查员控制药品生产和营销活动的权力似乎比预期的要小。更糟糕的是,缺乏政策支持,以在国家内部和国家之间采用更统一和系统的检查方法。

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