GMP certification issued by the drug regulatory authority, valid for 5 years, from a certain point of view, it is equivalent to the regulatory authority recognized that the production enterprise within 5 years, its production activities in line with GMP standards. This is like the traditional space sterilization method of formaldehyde fumigation in pharmaceutical factories, because formaldehyde is a strong carcinogen and difficult to completely remove, so a single formaldehyde fumigation needs at least 24 hours, sterilization a shutdown of 2 to 5 days, so the manufacturer usually carries out a fumigation sterilization after a long time, but the microbial pollution source human, material, material, outdoor fresh air, etc., but every day in and out of the GMP workshop. The microorganisms brought in by it can not be killed in time, and it is easy to appear that microorganisms have actually exceeded the standard in a sterilization cycle. GMP is a daily activity, and it is not true that today's GMP compliance will be met tomorrow. Many companies are just for certification and certification, such as certification before certification after two faces, the inspector left, immediately do not operate according to the standard, which makes the certification certificate into a "FIG leaf" of illegal operation. Therefore, some countries only have GMP on-site inspection, there is no GMP certification, such as the FDA in the United States, on-site inspection will not issue a GMP certificate, only provide an EIR report.

The deep meaning of the cancellation of "GMP certification"

To some extent, the cancellation of GMP and GSP certification is a kind of streamlining administration and delegating power and releasing dividends. The cancellation of GMP certification marks the change of CFDA's regulatory functions and the clarification of regulatory ideas, and a CFDA that returns to the nature of scientific supervision is coming to us. The reduction in government approvals will give companies more autonomy, but it will also require them to have higher standards for themselves. This is good news for enterprises that already attach importance to quality management, but it is a threat to those who are accustomed to opportunistic and last-minute enterprises.