万特制药公司GMP知识培训教材(83页)金牌资料.pptVIP

First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service companies which also offer service to external customers. Our Sales in 2005 have been 27.4 million Euro. Bayer has ~ 94.000 employees worldwide and is investing Euro 1.9 million in research. First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service companies which also offer service to external customers. Our Sales in 2005 have been 27.4 million Euro. Bayer has ~ 94.000 employees worldwide and is investing Euro 1.9 million in research. Question: why shall the environment to be monitored? Chinese GMP gives a very clear requirement about monitoring that we must follow. In Chinese GMP(1998) chapter 3 and Appendix: Not only there are very clear requirement about periodically monitoring of T, humidity, microbial count and particle count, but the general requirement about environment which are related with monitored items. So our SOPs describe very specific monitoring procedures. Summary Personnel monitoring will be introduced in TU60 How to define alert level? Example: how to calculate alert level with historic data? Two restrictions as …, aims are to avoid … Give examples to explain: Action level: 100 cfu/ml - Calculated result: 8 cfu/ml defined alert level to: 10 cfu/ml - Calculated result: 58 cfu/ml defined alert level to: 50 cfu/ml Excluded the results of OoS, … which happened in abnormal situation. Logbook包括：仪器编号，组成，系列号，生产商及供货商信息，软件信息，使用记录，维护记录，校准或功能测试记录等 安装验证方案包括：IQ, OQ, PQ