从美国药品GMP历史解读GMP之本质，希望此贴对大家理解GMP的精髓有很大帮助。

无菌药品在使用前的无菌保证，是药品管理法规的要求。因此，必须有容器完整性（Container Closure Integrity-CCI）的验证和监测，以确保在无菌药品生产，质控，运输和储存，乃至产品有效期的整个生命周期过程中，产品不受微生物的污染，确保病人用药安全。目前各个国家的药政法规，都有提供容器完整性CCI的测试方法，但是没有提供具体细节，指导如何合理的选择方法，及评价一个无菌药品包装系统...

USP 发布了新的通论1228.1《Dry Heat Depyrogenation干热去热原》，该章节对干热去热原不再要求250℃*30min的去热原参数，也不再要求内毒素下降3个log。该章节对干热去热原定义了新的标准：认为关注待处理物料（如玻璃瓶）的内毒素负荷，和处理后物料的内毒素残留水平（当内毒素下降到≤ 0.1 EU时，该工艺被认为可以接受。），比单纯的关注内毒素下降度更有意义。解读如下：...

制药用水质量指南草案

These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP. They provide the EEA's harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures. If a question is not addressed, marketing-authorisation holders are encouraged to contact the European Medicines Agency (EMA) for further information. These questions have been produced to provide clarification or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents.

Q1. Whether you could actually request an extension of the time which you got allowed to respond for any request for additional information?A1. This is something which may be necessary in some situati...

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...

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...

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations1 计量吸入器（MDI）和干粉吸入器（DPI）产品 - 质量方面的考量

PA/PH/OMCL(08) 88 R5 计算机化系统的验证—附录2 复杂计算机化系统的验证生效日期：2018-08-01ANNEX 2 OF THE OMCL NETWORK GUIDELINE “VALIDATION OF COMPUTERISED SYSTEMS”“计算机化系统的验证”附录2VALIDATION OF COMPLEX COMPUTERISED SYSTEMS复杂计算机化系统的...