There is a certain correlation between the new GMP and the old GMP, but it can't be accurately corresponded to, and can only be roughly converted: Class A represents the 100-level clean area, Class B represents the 10,000-level clean area, Class C represents the 100,000-level clean area, and Class D represents the 300,000-level clean area, and the national standard and ISO standard can't be accurately corresponded to because of the different ways of calculating and the requirements.
The difference between the new GMP and the old GMP:
1, the reference standard is not the same
The new GMP is based on the European Union GMP as a blueprint, with reference to the WHO, the United States and Japan's GMP, and based on the actual situation of China's drug manufacturers.
The division of the old GMP is based on the division of clean rooms in the United States.
2, dynamic, static monitoring requirements have changed
The new GMP dynamic, static monitoring requirements;
The old GMP only static provisions, no dynamic requirements.
3, the different levels of the corresponding background description has changed
A level of static and dynamic are equivalent to ISO4.8, level B static ISO5, dynamic ISO7, level C static ISO7, dynamic ISO8, to level D, the level has been relatively low, so there is no dynamic requirements, only the static requirements for ISO8.
The old version of the GMP only There are requirements for static monitoring.
4, sedimentation bacteria and planktonic bacteria monitoring requirements have changed.
The new GMP has requirements for the monitoring of settled bacteria and planktonic bacteria; the old GMP has no requirements for the monitoring of settled bacteria and planktonic bacteria.
Expanded Information:
. p>China's new GMP has made considerable progress in terms of management and technical requirements compared with the 98th edition. In particular, the production of sterile preparations and APIs has put forward high requirements, the new version of GMP based on the EU GMP, taking into account the domestic gap, the WHO 2003 version as the bottom line.
The new version of GMP certification has two time nodes: drug manufacturers of blood products, vaccines, injections and other sterile drug production, should be in December 31, 2013 to meet the requirements of the new version of the drug GMP; other categories of drugs should be in the production of the new version of the drug GMP in December 31, 2015 to meet the requirements of the new version of the drug GMP. Enterprises (workshops) that have not met the requirements of the new version of drug GMP shall not continue to produce drugs after the above specified period.
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