隔离操作技术在2010版药品GMP实施中的应用现状、问题与建议

2010版药品GMP较1998版药品GMP新增了隔离操作技术方面的内容,极大地推动了隔离操作技术在我国制药行业的应用。目前,很多制药企业在实施2010版药品GMP过程中,已经开始积极使用隔离操作技术。但是,也存在很多问题,包括设计缺陷、人员培训不到位、文件可操作性不强、确认工作不充分、忽视日常维护、对隔离操作技术持消极态度等。针对这些问题,建议制药企业从设计源头把关,加强人员培训,细化文件,完善确认工作,完善日常维护,重视隔离操作技术的应用。制药企业在使用该项技术的过程中,要坚持因地制宜、软硬并重的原则。

Current Situation of Application of Restricted Access Barrier Technology in Implementation of 2010 Edition GMP,Problems Existed and Proposals

Compared with 1998 Edition Drug GMP, in 2010 Edition one, restricted access barrier technology was newly added, by which the application of this new technology had been greatly promoted. Currently restricted access barrier technology has been applied in many pharmaceutical enterprises in execution of 2010 Edition Drug GMP. But there exists some problems, including defects in design, deifciency in personnel training, weak operability of documents, not full approval for the performances, without attentions to routine maintenance and passive attitude to this technology. With respect to these problems, it was proposed in this article that pharmaceutical enterprises should grasp the design as a beginning, strengthen personnel training, prepare the documents in detail, improve the approval work and routine maintenance, and pay attention to the application of restricted access barrier technology. In the application of this technology, it shall be follow the rules that the application of this technology should be adapted to local situation, and both hardware and software be taken into the same account.