Global health authorities review and approval trends for CMC post approval changes 2018-2024 [0.03%]
2018-2024年全球卫生权威机构的CMC批准后变更评审及获批趋势分析报告
Karim Kacimi,Sunny Kamlesh Dave,Scott Roberts
Karim Kacimi
The approval and implementation of Chemistry, Manufacturing, and Control (CMC) post-approval changes (PACs) by global health authorities are often lengthy and unpredictable in terms of requirements and timeline, potentially leading to drug ...
Evaluation of the Effect of Single-Temperature Incubation on the Recovery and Behavior of Microbiota in the Context of Environmental Monitoring [0.03%]
单温度孵育对环境监测中微生物回收和行为影响的评估
Laura Bailac,Laura Arnaldi,Lisa Mallam et al.
Laura Bailac et al.
Environmental monitoring is essential for the prevention and control of microbial contamination. Accurate and reproducible monitoring is critical, and standardized precise conditions of incubation in regulatory documents for environmental s...
Thoughts on the Use of Prior Knowledge in Managing the Patient Safety Risk of Extractables and Leachables from Packaging Systems and Manufacturing Components/Systems [0.03%]
有关在患者安全风险管控中采用已知信息管理包装系统和生产组件/系统的可提取物和浸出物的思考
Dennis Jenke
Dennis Jenke
According to the current Stage 2b version of ICH Q3E, "the quality risk management process for E&L warrants a holistic strategy, leveraging prior knowledge â¦" where prior knowledge is that knowledge (or information) which is available to...
Application of Stage 3a Heightened Monitoring to Close Process Knowledge Gaps of Legacy Injectable Products: A Commercial Scale Case Study [0.03%]
三级A增强监控在 legacy 注射剂产品的工艺知识差距中的应用：一项商业规模案例研究
Ajay Babu Pazhayattil,Avinash Joshi,Marzena Ingram
Ajay Babu Pazhayattil
Legacy sterile injectable products developed prior to the widespread adoption of Quality by Design (QbD) principles are often entered into the product lifecycle with a limited quantitative understanding of process variability. FDA's Process...
Comparative Study of Matrix vs. Product-Specific Cleaning Validation Approaches [0.03%]
矩阵与产品专用清洁验证方法的比较研究
Mahender Boyapally
Mahender Boyapally
Cleaning validation is an essential part of the present Good Manufacturing Practices (cGMP) of the pharmaceutical industry. This comparison paper discusses two main cleaning validation methods: the matrix (worst-case) approach and product-s...
Beyond Batch Release: Responsible Decision-Making, Professional Judgement, and Governance in Complex Pharmaceutical Manufacturing [0.03%]
超越批次放行：复杂药品制造中的负责任决策、专业判断和治理
Mario Stassen
Mario Stassen
Responsible decision-making in pharmaceutical manufacturing increasingly occurs within complex, distributed, and rapidly evolving environments. While the European Qualified Person (QP) holds defined regulatory accountability, modern decisio...
Determination of Trace Nitrosamines in Plastic Pharmaceutical Packaging Materials [0.03%]
塑料药包材中亚硝胺杂质的检测方法研究进展
Lukas Jost,Frank Sprau,Lukas Thörner et al.
Lukas Jost et al.
Nitrosamines are classified as probable (IARC Group 2A) or possible (IARC Group 2B) human carcinogens, capable of inducing tumors even at very low concentrations (nanogram per liter levels). Regulatory considerations specifically affect Lar...
Manufacturing CAR T Therapies: A Review of Methods, Controls, and Innovations for Scalable, Accessible Treatments [0.03%]
CAR-T疗法制备工艺研究：规模化与普及型治疗手段的方法、管控及创新综述
Jose A Caraballo-Oramas
Jose A Caraballo-Oramas
Chimeric antigen receptor (CAR) T cell therapies have transformed the treatment of hematologic malignancies, providing meaningful clinical outcomes for patients with limited therapeutic options. However, the complexity of these therapies pr...
Pinch Force Endurance and Usability Considerations for Pre-filled Syringe Designs Used by Chronic Obstructive Pulmonary Disease Patients [0.03%]
慢性阻塞性肺疾病患者使用的预装注射器设计的捏力耐受性和可用性考虑因素
Xueke Wang,Jaclyn Baron,Joanna So et al.
Xueke Wang et al.
Background Prefilled syringes (PFS) are commonly used for self-administered injectable drugs, particularly for chronic conditions. A critical design factor is the injection force needed to depress the plunger, which varies by drug viscosity...