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本帖最后由 flong 于 2018-6-14 19:23 编辑
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry.
制药业过程分析技术术语
E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology.
应用过程分析技术进行制药工艺设计的实践。
E2475 Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
与药品生产和控制有关的工艺理解指南
E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture.
为制药的影响PAT工艺设计,开发和操作的风险评估和风险控制指南
E2537 Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing.
在制药和生物制药生产中持续质量确认应用指南。
E2629 Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems.
过程分析技术(PAT)启用控制系统验证指南。
ASTM E2500 - 13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
药品和生物制药制造系统和设备的规范、设计和验证的标准指南。
Subcommittee E55.03 on General Pharmaceutical Standards
关于一般制药标准的E55.03小组委员会
Showing results 1-8 of 8 matching ACTIVE standards under the jurisdiction of E55.03
显示E55.03管辖范围内的8项现行标准中的1-8项
E55 Home https://www.astm.org/COMMIT/COMMITTEE/E55.htm
E55 主页:https://www.astm.org/COMMIT/COMMITTEE/E55.htm
E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
制药和生物制药制造系统和设备的规范、设计和验证标准指南
E2503-13e1 Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
篮子和桨溶解装置合格的标准实施规程
E2656-16 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
制药用水总有机碳实时检测标准
E2810-11e2 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
含量均匀度检测合规能力证明标准规程
E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
制药和生物制药制造中一次性使用系统的规范、设计、验证和应用的标准指南
E3060-16 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
使用动态(流动)成像显微镜的生物制药制造中的可测量颗粒的标准指南
F838-15a Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
测定液体过滤用膜过滤器的细菌保留率的标准试验方法
WK15778 New Guide for Science-based and Risk-based Cleaning Process Development and Validation.
基于科学和风险的清洁工艺开发和验证的新指南。
WK51651 Standard Guide for Raw Material eData Transfer between Pharmaceutical & Biopharmaceutical and their Suppliers.
制药和生物制药及其供应商之间原料电子数据转移的标准指南。
WK52609 Standard Practice / Guide for Validating End-user Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products.
制药、生物制药、生物产品的最终灭菌过滤器验证指南
上面差不多是ASTM所有制药方面的标准,本论坛大部分都没有。
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