广东省洁净技术行业协会
GMP认证 国内药企需努力缩短与国际GMP认证距离
- 发布时间：2012-05-30
- 编辑：
GMP认证 国内药企需努力缩短与国际GMP认证距离
GMP certification the pharmaceutical enterprises need to shorten the distance with the international GMP certification
2012年势必是医药企业兼并重组、提速发展的重要战略年。去年年底，国务院常务会议讨论通过了《国家药品安全规划(2011-2015年)》，明确了“十二五”期间药品安全工作的总体目标和重点任务，强调到2015年，药品生产必须100%符合新版GMP要求。
2012will be pharmaceutical mergers and reorganization of enterprises, to speed the development of important strategic years. At the end of last year, the State Council executive meeting to discuss through the" national drug safety plan (2011 -2015)", made clear "925" during the period of drug safety and the overall goal and key task, emphasize to 2015, pharmaceutical production must meet requirements of GMP100% new.
中投顾问医药行业研究员郭凡礼指出，新版GMP认证国内药企通过率较低，其中很重要的一个原因是新版GMP认证对硬件设施要求比较高，同时对国内药企产能及产量提出了更高的要求。国内药企要进行全面宣传培训、加强监督检查，促进药企进行技术升级，实现产业化改造，努力缩短与国际GMP认证接轨距离。
The consultant in the pharmaceutical industry researcher Guo Fanli pointed out, a new version of the GMP certification of domestic pharmaceutical enterprises through rate is low, which is a very important reason is the new version of GMP certification on the hardware requirements are relatively high, while the domestic pharmaceutical production and yield put forward higher requirements. Domestic pharmaceutical enterprises to conduct a comprehensive propaganda and training, strengthen the supervision and inspection, to promote enterprises to upgrade technology, realize industrialization reform, strive to shorten the distance with the international GMP certification standards. http://www.cnqr.org中国质量认证网
郭凡礼指出，新一轮GMP认证有利于整治药企行业盲目跟风重复建设的现象，这也将进一步提升产品质量，加强人员素质的培养力度。此外，资金直接影响药企新一轮GMP认证的速度。药企一方面要争取跟国际GMP认证接轨，另一方面要着手于企业经营效益的提高，才能有效抵御退出市场等毁灭性风险。
Guo Fanli pointed out, a new round of GMP certification for remediation of pharma industry blindly repeated construction of the phenomenon, this will further enhance product quality, enhance the quality of personnel cultivation. In addition, a new round of funding directly affect the pharmaceutical GMP certification speed. Their hand to fight with the international GMP certification standards, on the other hand to hand in the business efficiency, can effectively resist the withdrawal from the market and other destructive risk.
新版GMP对企业的硬件建设要求比较高，国内药企要正确定位自己产品所需要的检测标准、根据实际需求灵活调配资金。此外要积极拓宽融资渠道、筹集足够的资金以支持新版GMP对企业的硬件建设。中小企业要根据新版GMP对企业的硬件建设制定一套详尽的可行的采购计划。新版GMP对企业的软件建设也要进行实时跟踪，方能确保新版GMP能够让企业得到真正的实惠。
The new version GMP enterprise hardware construction requirements are relatively high, the domestic pharmaceutical enterprises to correct positioning of their products required by the testing standards, according to the actual needs of flexible deployment of capital. In addition to actively widen financing channel, raise enough funds to support the new version GMP enterprise hardware construction. Small and medium-sized enterprises according to the version of GMP on the hardware construction established a detailed feasible purchasing plan. The new version of GMP on the building of enterprise software for real-time tracking, we can make sure that the new GMP can make enterprises get real benefits.
郭凡礼同时表示，比较前一轮和国际认证，制药行业新版GMP认证今后工作应逐步完善制药行业新版GMP认证硬件配套设施；加强对制药行业新版GMP认证软件人员配置；药企在生产过程中严格执行新版GMP认证中的要求，对全过程实施现全面质量管理及跟踪服务；在具体操作过程中，要严格遵守标准作业流程的规范，从源头上严把质量关，确保药企在GMP认证中能顺利通过。
Guo Fanli said at the same time, compared with the previous round and international certification, the pharmaceutical industry a new version of the GMP certification in future work should gradually improve the pharmaceutical industry a new version of the GMP authentication hardware facilities; to strengthen the pharmaceutical industry a new version of the GMP authentication software staffing; pharmaceutical companies in the production process strictly enforce the GMP certification requirements, the whole process of the implementation of the total quality management and tracking services; in the concrete operating process, must strictly abide by the standard operation procedure specification, from the source to the strict quality control, to ensure that enterprises in GMP attestation to pass.
GMP认证 国内药企需努力缩短与国际GMP认证距离
GMP certification the pharmaceutical enterprises need to shorten the distance with the international GMP certification (责任编辑：奔跑的稀饭)
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