eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010.doc

eu gmp annex 11 中文 WHO GMP Sterile 2010 Annex 4 TRS957_2010 导读：就爱阅读网友为您分享以下“WHO GMP Sterile 2010 Annex 4 TRS957_2010”的资讯，希望对您有所帮助，感谢您对92的支持! Table 2 Examples of operations to be carried out in the various grades 4.8 To control the microbiological cleanliness of the cleanliness grades A–D in operation the clean areas should be monitored. Where aseptic operations are performed, monitoring should be frequent using methods such as settle plates, volumetric air and surface sampling (e.g. swabs and contact plates). Sampling methods used in operation should not interfere with zone protection. Results from monitoring should be considered when reviewing batch documentation for ? nished product release. Surfaces and personnel should be monitored after critical operations. Additional microbiological monitoring is also required outside production operations, e.g. after validation of systems, cleaning and sanitization. 4.9 Levels of detection of microbial contamination should be established for the purpose of setting alert and action levels and for monitoring the trends in environmental cleanliness in the facility. Limits expressed in colony-forming units (CFU) for the microbiological monitoring of clean areas in operation are given in Table 3. The sampling methods and numerical values included in the table are not intended to represent speci? cations, but are for information only. Table 3 Recommended limi