对于类似Excel电子表格类的应用程序，在合规领域GxP（GLP、GMP、GCP）使用时，必须是受控的和经过验证确认的。人们通常有一些误区。一种极端是认为Excel具有很多缺陷，不能在合规环境中使用，另外一个极端是认为Excel这种在全球商业领域广泛应用的软件必然是经过实践检验的，受到公认的，不需要验证了，但FDA恰恰没有对任何软件给予这种免于验证的豁免权，当然也没有说Excel就完全不能在其监管...

电子表格软件是使用最广泛，最受各种企业青睐的软件之一。电子表格软件中的杰出者Excel以其易用性和灵活性在各行各业都有十分广泛的应用。用户往往不需要什么培训或使用经验就可以独立操作Excel软件。同时，灵活性和应用的广泛性也使得在应用开发和操作时出现错误的概率大大增加。最新的调查表明，超过90%的电子表格都存在错误。由于Excel并非是专为合规环境而设计的，因此对电子表格和其产生的数据进行验证也变...

1.美国和欧盟GMP的原则是:1）当用无菌工艺生产无菌API或制剂时，在无菌性方面的要求是一致的，无任何变化。2）如无菌活性成分(APIs)直接分装成制剂，则无菌制剂的GMP要求适用于APIs生产。2.药品质量管理规范(GMP)在各国的习惯称呼有所不同。美国使用缩写CGMP，而欧洲，日本和其他地区缩写成GMP。3.有6个工艺步骤建议需要对时间进行控制:1）配制至灭菌的时间；2）过滤时间；3）生产线...

GAMP® 5·         GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems·         GAMP 5: 保证GXP计算机系统符合性的基于风险的方...

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...

ABSTRACT Production 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...