2019年11月26日 · There has been increasing evidence in recent years that research in life sciences is lacking in reproducibility and data quality. This raises the need for effective systems to improve data integrity in the evolving non-GxP research environment.

GxP is like a Michelin-starred restaurant: Every ingredient is sourced, measured, and cooked to perfection. No room for improvisation! Non-GxP is like your college dorm kitchen: Ramen, questionable leftovers, and a general "eh, it'll be fine" attitude. Here's what GxP is all about:

2020年9月14日 · GMP是一套适用于制药、食品等行业的强制性标准，要求企业从原料、人员、设施设备、生产过程、包装运输、质量控制等方面按国家有关法规达到卫生质量要求，形成一套可操作的作业规范帮助企业改善企业卫生环境，及时发现生产过程中存在的问题，加以改善。 简要的说，GMP要求制药、食品等生产企业应具备良好的生产设备，合理的生产过程，完善的质量管理和严格的检测系统，确保最终产品质量（包括食品安全卫生等）符合法规要求。 GAP：《中药材 …

GLP认证是指国家食品药品监督管理局对药物非临床安全性评价研究机构的组织管理体系、人员、实验设施、仪器设备、实验项目的运行与管理等进行检查，并对其是否符合GLP作出评定。 GLP认证分为申请与受理、资料审查与现场检查以及审核与公告三大环节。 GMP 是针对药厂生产的 GLP是针对药物实验室的. 60年代震惊世界的“反应停”事件，德国、加拿大、日本、欧洲等17个国家的妊娠妇女用“反应停”治疗妊娠呕吐而造成12000余例“海豹肢畸形”婴儿。 该事件就是药物审 …

2024年10月23日 · Explore the key differences between GXP and non-GXP in healthcare. Understand their significance, regulatory requirements, and how they impact product quality a

There has been increasing evidence in recent years that research in life sciences is lacking in reproducibility and data quality. This raises the need for effective systems to improve data integrity in the evolving non-GxP research environment.

First comprehensive book on factors associated with high risk for poor reproducibility of non-clinical findings; Inclusion of aspects of study design, data analysis and data reporting; Broad applicability to in vitro and in vivo research across all therapeutic areas

2022年10月26日 · The main difference between GxP and non-GxP is that when something abides by GxP the responsible person takes great measures to assure the safety and quality of products, placing special attention on traceability and data integrity. Non-GxP usually refers to something that isn’t GxP compliant or that isn’t required to be GxP compliant.

2019年11月26日 · There has been increasing evidence in recent years that research in life sciences is lacking in reproducibility and data quality. This raises the need for effective systems to improve data...

There has been increasing evidence in recent years that research in life sciences is lacking in reproducibility and data quality. This raises the need for effective systems to improve data integrity in the evolving non-GxP research environment. This …