What are the new changes in the new version of GMP dust-free workshop
Since July 1, 1998, the 'Drug Manufacturing Enterprise License' shall not be issued to the Suzhou Fama dust-free workshop that has not obtained the drug GMP certification; the Ministry of Health will not accept the production of the enterprises that have not obtained the drug GMP certification. Application for a new drug. GMP is a compulsory certification for the pharmaceutical industry. If a pharmaceutical factory does not pass the GMP certification, it is illegal. It can be seen that the state attaches great importance to the safe production of drugs. GMP has gone through many versions since 1995, which means that enterprises must have good production standards. Now the latest version of GMP is 2010. What are the new changes in the new version of GMP dust-free workshop? It is mainly reflected in the following aspects: 1. Higher requirements than in the past have been put forward for the purification air conditioner in terms of level, system, airflow and detection. 2. For the background environment of the high-risk operation area, a cleanliness requirement 100 times higher than in the past is put forward. 3. The requirements for system operation are put forward for the purification and air conditioning system of sterile medicines. 4. In addition to static monitoring of suspended particles, dynamic monitoring is also required. 5. A new requirement is put forward for the number of air changes in the turbulent clean room. 6. The requirements for the cross-sectional wind speed of the workbench in the laminar flow area are not raised by the old version of GMP in 1998, and are higher than those of the conventional Suzhou Fama dust-free workshop. 7. Put forward beyond professional requirements for the effect of airflow. 8. The index of surface contamination was proposed. 9. Appropriate requirements for lighting and temperature and humidity are only put forward, but inappropriate figures are not given. 10. The first request for isolation operation was put forward. 11. A high requirement of not less than 10Pa is put forward for the pressure difference between adjacent clean rooms of different levels, and the adjacent rooms of the same level should also have an appropriate pressure difference. To sum up, the old version of GMP in 1998 only advocated that pharmaceutical companies should have this awareness, while the new version of GMP in 2010 put forward very clear requirements and indicators for various purification indicators of the dust-free pharmaceutical cleanroom of Suzhou Fama.
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