DATA INTEGRITY MATURITY LEVEL CHARACTERIZATIONMaturity AreaMaturity FactorsMaturity   Level CharacterizationLevel 1Level 2Level 3Level 4Level 5Cluture•  DI   Understanding and awareness...

CFDA附录《计算机化系统》要求：第七条  企业应当建立包含所有计算机化系统的清单，标明与药品生产质量管理相关的功能。清单应当及时更新。这个清单怎么建立，包含哪些内容，看完以下分类，你再决定怎么做……一、药厂常见计算机系统分类（A类：嵌入式计算机系统）1、现场安装的智能化传感器、显示仪（嵌入式计算机）温度、压力、流量、风速、转速、PH、电导率……在线仪表。2、现场安装的智能化仪...

On 30 April 2018, the EMA published the final, revisedversion of the Q&A document with its focus on setting health-based exposurelimits for risk identification and the risk-based prevention ofcros...

Introduction简介Due to the dynamic nature of technological changes and dataintegrity requirements companies are faced with the challenge of frequentlymigrating data from legacy systems.基于不断变化的技术新变革和数据完整...

ABSTRACTProduction lots and tests with a specification range of two standard deviations will produce random rejections five percent of the time, as a result of extreme statistical variation. Techniques based on sound statistical reasoning were developed to deal with out-of-specification (OOS) test results. The temptation to bend the rules and lower the reject rate led to abuses, however. The most common of these was to test a sample repeatedly until a passing result was produced. In 1993, Barr Laboratories lost a lawsuit on this and related points and the judge's decision led to new interpretations of FDA rules, including the requirement that an investigation be initiated before a replicate sample can be tested. These rules and others incorporated into FDA guidance documents reflect a misunderstanding of important statistical principles.

1. Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control Revised 2007 (Published 1980) 湿热灭菌工艺验证：循环设计、研发、确认和持续控制，修订20073. Validation of Dry...

Guide to General Chapters   通用章节指导（标注底色部分为USP40-NF35新增章节）General Requirements for Test and Assays　　检查与含量分析的一般要求＜1＞INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS&n...

ACE test 爱斯牌甲醛灭菌用生物指示剂型号∶H6305用途∶甲醛灭菌指标菌∶Bacillus atrophaeus芽孢数∶1×106以上盖子颜色∶蓝包装∶100支／盒产品简介：  甲醛灭菌生物指示剂用于测定甲醛对细菌芽孢的杀灭能力及甲醛消毒、灭菌效果的生物监测。甲醛灭菌生物指示剂由枯草杆菌黑色变种芽孢(ATCC9372)菌片（载体为玻璃纤维），培养基（密封在玻璃管内）及塑...

菌种Geobacillus stearothermophilus NBRC12550 (ATCC 12980)培养基成分培养基：大豆蛋白胨培养基指示药：溴甲酚紫指示剂使用范围用于汽化过氧化氢空间灭菌效果监测。保管上的注意请在2～25℃、20%～80%RH避光保管。（培养基请在2～10℃保管。）请在远离灭菌器和消毒杀菌剂之处保管。使用前的注意使用前请确认有效期限。使用前请确认产品的完整性。如冷藏保存...

产品简介：  低温蒸汽甲醛（LTSF）灭菌生物指示剂(105)：用于测定LTSF低温蒸汽甲醛灭菌器对细菌芽孢的杀灭能力，以验证其灭菌性能是否符合原设计规定及LTSF低温蒸汽甲醛灭菌效果的生物监测。低温蒸汽甲醛（LTSF）灭菌生物指示剂(105) 由嗜热脂肪杆菌芽孢(ATCC7953)菌片（载体为玻璃纤维），培养基（密封在玻璃管内）及塑料外壳组成自含式生物指示剂。菌片含菌量为1×...