Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review [0.03%]
ICH Q5A(R2)后的多公司合作评估病毒清除研究中树脂循环的影响-病毒清除研究中重复使用树脂的回顾性评价
Jennifer Anderson,Chelsea Burgwin,Donna Hamilton
Jennifer Anderson
In 2019, the BioPhorum Development Group Viral Clearance Workstream performed a collaborative retrospective analysis to evaluate packed bed chromatographic resin performance after repeated cycling for two commonly used chromatography steps ...
Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot [0.03%]
全球监管互信：化学品、生产和控制审批后变更试点的执行结果
Cynthia Ban,Jamie Graham,Lyne Le Palaire et al.
Cynthia Ban et al.
Post-approval changes (PACs) are integral to pharmaceutical product lifecycle management ensuring that the product remains safe, effective, and compliant with evolving standards. However, managing these changes across multiple regulatory ju...
Preservative efficacy testing of refrigerated pharmaceuticals: choice of challenging isolate and storage temperature [0.03%]
冷藏药物防腐效能试验中挑战认证菌和储存温度的选择
Seyed Sadeq Mousavi Ghahfarrokhi,Zeinab Zarei,Khadijeh Hamidian et al.
Seyed Sadeq Mousavi Ghahfarrokhi et al.
The antimicrobial effectiveness testing assesses the performance of preservatives and/or antimicrobial substances added to multi-use sterile or non-sterile dosage forms, protecting these products from microbiological growth. In this study, ...
A proof-of-concept study on a universal standard kit to evaluate the risks of inspectors for their foundational ability of visual inspection of injectable drug products [0.03%]
评估注射药物基础视觉检测能力的通用标准套件的风险概念验证研究
Hirohito Katayama,Manabu Tsuda,Yukari Koga et al.
Hirohito Katayama et al.
Visual inspectors' ability to detect foreign matter in injections must be qualified for each product type or bracketing group, as stated in the United States Pharmacopeia . The common defect criterion is ″visible″ However, this qualitativ...
Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing [0.03%]
生物制药多阶段特征选择和交互作用的相增量决策树
Nolan Gunter,Yang Tang,Jonathan Ritscher et al.
Nolan Gunter et al.
Data from cell culture processes contain myriad parameters arriving sequentially in phases which may hold vital information for optimizing process runs and ameliorating manufacturing yield. This study analyzed temporal process data from 249...
Practical application of setting up an annual Contamination Control Strategy (CCS) assessment [0.03%]
年度污染控制策略(CCS)评估的实际应用
R van der Galiën,A L Langen,L J M Jacobs et al.
R van der Galiën et al.
A Contamination Control Strategy (CCS) is a strategy that focuses on how to prevent contaminations with microorganisms, particles and pyrogens and manages risks to medicinal product quality and patient safety within a GMP facility. A CCS sh...
Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP Visible Particulates in Injections [0.03%]
封装在不透明和半透明容器中的局部眼科制剂的视觉检查：与美国药典注射剂中可见颗粒保持一致的工作步骤
Mary Lee Ciolkowski,Ann T Davis,Alexa Harding et al.
Mary Lee Ciolkowski et al.
Topical ophthalmic solutions, suspensions, and emulsions are typically packaged in opaque or semi-transparent plastic dropper bottles. This packaging provides resistance to breakage and the controlled drop size needed in ophthalmic containe...
Ghada Haddad
Ghada Haddad
Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys [0.03%]
理解实验室执行可提取物筛选研究的对齐性：ELSIG 实验室实践小组行业调查的结果
Steven A Zdravkovic,Qiang Fu,Aaron Flick et al.
Steven A Zdravkovic et al.
Substances that can be extracted (extractables) from the components of a medical device or a pharmaceutical product's manufacturing, packaging, and/or delivery system(s) are characterized as part of an extractable screening study to ensure ...