蒸汽灭菌和冻干工艺的验证及风险分析(PPT 131页)

GMP & VALIDATION
GMP & VALIDATION
Validation
Terminal Moist-Heat Sterilization
What is being Sterilized?
Porous Loads
Hard Goods
Equipment Parts
Components
Glass
Stainless steel
Polymeric Materials
Waste Liquids
Defining the sterilization process
Balance must be Maintained
Attaining sterility must not be accomplished with loss of
product stability.
Maintaining stability must be accompanied with adequate
assurance of sterility.
Validation approaches
Biological Indicator Evaluator Resistometer
Validation issues
Validation – Calibration
Validation – leak test
Heat distribution and penetration
Temperature mapping
Lethality maps
Possible failure causes
OPERATIONAL QUALIFICATION 
Verification of shelf temperature
..............................

上一篇：政策性银行风险监管培训教材(PPT 50页)

下一篇：个人信用风险敞口及降低信用风险教材(PPT

投资风险管理教材(DOC 65页)

风险与收益培训课程(PPT 129页)

风险投资行业年度报告分析(doc 77页)

污染生态风险评价(ppt 63页)

金融危机下中小企业财务风险控制问题的探析(pdf 59页)

风险的市场价格(PPT 42页)