设施设备(闫兆光)教案解析.ppt

World Health Organization * * World Health Organization * * World Health Organization * * World Health Organization * * Product life cycle includes research and development, product and distribution Product must be exactly as demonstrated during the clinical trials. Any major change since that period must have a Change Control with a NRA approval World Health Organization * * Product life cycle includes research and development, product and distribution Product must be exactly as demonstrated during the clinical trials. Any major change since that period must have a Change Control with a NRA approval World Health Organization * * Product life cycle includes research and development, product and distribution Product must be exactly as demonstrated during the clinical trials. Any major change since that period must have a Change Control with a NRA approval World Health Organization * * Product life cycle includes research and development, product and distribution Product must be exactly as demonstrated during the clinical trials. Any major change since that period must have a Change Control with a NRA approval World Health Organization * * Product life cycle includes research and development, product and distribution Product must be exactly as demonstrated during the clinical trials. Any major change since that period must have a Change Control with a NRA approval World Health Organization * * World Health Organization * * World Health Organization * * 4.5 Cross-contamination 4.5.1 Where different products are manufactured at the same time, in different areas or cubicles, in a multiproduct OSD manufacturing site, measures should be taken to ensure that dust cannot move from one cubicle to another. 4.5.2 Correct directional air movement and a pressure cascade system can assist in preventing cross-contamination. The pressure cascade should be such that the direction of airfl ow is from the clean corridor into the cubicles, resulting in dust containmen