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GMP certification

What impact does the implementation of the newly revised pharmaceutical GMP have on China's pharmaceutical industry?

The newly revised drug GMP fully refers to the international advanced standards such as the World Health Organization and the European Union. The requirements for the production of sterile drugs have been greatly improved. It is more important to emphasize the effective operation of the entire process quality management system and the quality of the entire process of drug production. Risk control to more effectively guarantee the quality and safety of medicines. New revision ... [detailed]

After January 1, 2014, will the suspension of non-certified companies impact the industry?

According to statistics, only 22 of the top 500 pharmaceutical companies in the country involved in the production of injectables have not applied for the newly revised drug GMP certification. 99 of the top 100 companies have passed, and only one company has submitted an application for certification. The newly revised drug GMP is an increase in technical requirements and a choice made by the market in the new stage of industrial development. But ... [detailed]

In the next step, what measures will the General Administration take to supervise the enterprises that have not passed the certification to ensure that the shutdown measures are in place?

All localities must seriously implement the requirements of the Announcement, and any sterile drug manufacturers or production workshops that have not passed certification for blood products, vaccines, injections, etc. must stop production on January 1, 2014. All localities are requested to immediately notify the enterprises that have not passed the GMP certification of pharmaceuticals, and all pharmaceutical production activities shall be stopped in accordance with the requirements of the Announcement ... [Details]

Why implement the new revised drug GMP?

The Good Manufacturing Practice (GMP) is an internationally accepted basic standard for quality management of pharmaceutical production. It is an important technical standard that must be followed in pharmaceutical production. It has become an essential element in the evaluation of the quality assurance system and participation in international pharmaceutical trade. standard. Pharmaceutical GMP on raw materials in pharmaceutical production ... [Details]

What are the measures to promote the implementation of the newly revised drug GMP?

In view of the slow progress in some regions and the wait-and-see situation of enterprises in the early stage of implementation, the problem of imbalanced implementation progress is more prominent. In particular, aseptic drug production must achieve the expected goals by the end of 2013, and the task is particularly urgent. Therefore, the Food and Drug Regulatory Department and the Development and Reform Commission, the Ministry of Industry and Information Technology, the original health ... [Details]


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