广西制药企业实施新版GMP存在的主要问题及其对策-中药学专业论文.docxVIP

Guangxi pharmaceutical companies implementing major issues and countermeasures in new GMP ABSTRACT Objective:Through making questionnaire research some of representative pharmaceutical companies in Guangxi , In order to find out the problems to give suggestions and advice, which are existed and encountered by enterprises when they implement the new GMP. Through providing reference to help those industries deal with business problems and speed up guangxi pharmaceutical companies passing the inspection of authentication, and promote the healthy development of the pharmaceutical industry in our province. Methods:Through several enterprises in Guangxi to conduct research, and corporate quality manager in the form of questions and answers to chat and fill out the questionnaire form and design of the questionnaire for employees within the questionnaire. The use of data processing software for the analysis and synthesis analysis investigated the contents analyzed and discussed, and the corresponding countermeasures. Results:Pharmaceutical companies for participating in the survey are three large（nanyao、sanjin、tianhe), three medium (jiqi、huiang、bainianle) and two small（jinying、jinwang). As well as to the pharmaceutical enterprises in guangxi, guangxi wuzhou pharmaceutical group in-depth analysis. The main problem exists in Guangxi pharmaceutical companies from the main to the secondary are: hardware and software, personnel, training, validation, strong wait-and-see attitude, funding, on-site inspection. Conclusion:In the face of the implementation of the new version of GMP, pharmaceutical production enterprise problems are mainly the heavy hardware input and despise software implementation, did not grasp the essence of the new GMP, waiting on the sidelines, to oneself enterprise whether can pass the new GMP is not very confident, the whole personnel quality is low, restricts the new version of GMP will go smoothly, the training does not reach the designated position, affec