GMP workshop cleanliness standards are as follows:
The air temperature in the clean operation area should be 18 to 26 degrees Celsius. The relative humidity of the air in the clean operation area should be 45% to 60%. The number of room air changes: more than or equal to 15 times per hour. Differential pressure: 100,000 level area relative to the outdoor greater than or equal to 10 Pa. Leakage detection of high-efficiency filters is greater than 99.97%. illuminance: greater than 300lx-600lx. noise: less than or equal to 75db.
1, "Good Manufacturing Practice of Medical Products" (GMP), "Good Manufacturing Practice of Medical Products" (GMP), "Good Manufacturing Practice of Medical Products" (GMP), "Good Manufacturing Practice of Medical Products" (GMP). Good Manufacturing Practice of Medical Products (GMP) is a basic guideline for drug production and quality management, applicable to the whole process of drug preparation production and the key processes affecting the quality of finished products in the production of APIs. The vigorous implementation of GMP is an important measure to improve the quality of medicines in order to maximize the avoidance of contamination and cross-contamination in the process of drug production and to reduce the occurrence of various errors.
2, the World Health Organization, in the mid-1960s began to organize the development of drug GMP, China began to implement the 80's. 1988 promulgated China's drug GMP, and in 1992 made the first revision.
Over the past ten years, China's implementation of pharmaceutical GMP has made certain achievements, a number of pharmaceutical enterprises (workshops) have passed the pharmaceutical GMP certification and standards, and promote the pharmaceutical industry to improve the level of production and quality. However, from a general point of view, the implementation of drug GMP is not strong enough, and some of the contents of drug GMP also need to be modified accordingly.
3, the new GMP cleanliness level A, B, C, D "Good Manufacturing Practice (2010 Revision)" (the new version of the GMP) came into force on March 1, 2011, iwuchen in this article mainly introduces the new version of the GMP on the cleanliness level of the four levels of A, B, C, D, as well as the new version of the cleanliness level of the GMP standard. a clean area:< /p>