As "excessive capsule chrome event", "shu" fake drugs, "qi effectively event", "ShuangHuangLian event", "xin, incident" and a series of important adr events occur frequently, touched a nerve fragile public, made after the collapse of public trust in a short period of time is difficult to rebuild and drug safety in China is facing the most severe challenges.
At the moment, the public opinion, drug safety problems emerge in endlessly, should be attributed to two reasons: lack of government supervision and absence of medicine enterprise quality management.
"Since March 1, 2011, every new pharmaceutical producing enterprises, pharmaceutical production enterprise workshop (change and expansion) shall conform to the requirements of the new drug GMP. Existing pharmaceutical producing enterprises, vaccines, blood products, such as injection asepsis pharmaceutical producing, should be in December 31, 2013 to fulfill the requirements of the new drug GMP. The production of other kinds drugs shall be on December 31, 2015 to fulfill the requirements of the new drug GMP. Do not meet the new drug GMP requirements of the enterprise (workshop), after the time limit specified in the above shall not continue to produce drugs."- "in drug production quality management standard (revised in 2010).
A new version of GMP on software and hardware requirements for drug firms all set a higher standard, especially for the quality management system in drug production process quality control and assurance process, how to adopt a more scientific, efficient and accurate means, to ensure drug production to meet the basic requirement of safe, effective, quality control, has become the major headaches for many companies.
On the one hand, the enterprise is eager to use effective means to standardize the management of enterprise internal processes, and in a timely manner to get the related quality data statistics analysis, change numerous for brief;, on the other hand, enterprises are eager to establish the quality management information database, the realization of the sharing of information resources to quantitative assessment personnel, improve the work efficiency.
Under the trend of The Times, make enterprise from slowly from profits and production to focus on quality construction, to pass a new version of GMP as the top priority, begin to contact quality management information technology, the pharmaceutical quality control system is also this case into the corporate vision, and by the enterprise gradually known and accepted.
Only the new standard of GMP pharmaceutical production enterprise as the enterprise continuously deepen the real execution of powerful weapons, can in the increasingly fierce market competition in the future we will continue to implement the brand strategy, quality to improve the core competitiveness, usher in a broader space for development.
A new version of GMP certification, the domestic many LIMS suppliers still stay in the laboratory is in charge of the business development, completely ignore the current pharmaceutical industry demand for comprehensive quality management, especially on the quality assurance and quality control.The current laboratory management system of LIMS suppliers can only solve the tip of the iceberg, unable to help drug companies to establish a perfect quality management system, make a new version of GMP in medicine enterprise perfect landing.
Zhuhai flight prices according to the different requirements of many drug company serious investigation, reference of many pharmaceutical industry experts, for the first time the pharmaceutical industry of quality assurance, quality control, production management, material management and equipment management in the information management, in the true sense meets the requirements of the quality of the pharmaceutical industry the comprehensive construction, LIMS informatization in China come to pioneer research and development and service.
In October 2011, FE GMP pharmaceutical quality control system based on the new design has the function of the system to help group smoothly through the new method shows GMP certification, has got the thumbs up from the height of the provincial food and drug administration departments and recognition, won the provincial food and drug administration's authoritative magazine "China AP drug quality authorized person" is the key recommendation specifies the only product title, and invited to participate in the second session of Chinese drug safety and quality control of congress.
