必须重申的是,在试验机构中引入GLP,以及在GLP应用培训时,必须明确区分“良好实验室规范(good laboratory practice)”一词的正式、规范使用,与“良好实践(good practice)”在科学研究中的一般应用。由于“良好实验室规范”一词不是受商标保护的术语,任何可能认为自己在日常工作中遵循良好规范的实验室都可能试图用这个术语...
products are designed and developed in accordance with the requirements of this document and other associated guidelines such as good laboratory practice (GLP) (3), good clinical practice (GCP) (2) and good storage and distribution practices (GSDP) (4), where appropriate; 根据本文档和其他相关指...
the World Health Organization (WHO) Prequalification Inspection Services Team (PQT INS) raised the urgency for the development of good manufacturing practice (GMP) text to address the manufacturing of developmental batches, pilot batches and the sequential stability...
productsare designed and developed in accordance with the requirements of this documentand other associated guidelines such as good laboratory practice (GLP) (3) , good clinical practice (GCP) (2) and good storage and distributionpractices (GSDP) (4) , whereappropriate; 产品根据本文件和其它相关指...
11月11日,世界卫生组织(WHO)发布了“研究和开发设施的良好实践” 指南(Good practices for research and development facilities)的征求意见稿。WHO指出,就开发批、中试批生产以及相应的稳定性数据,目前没有相关的法规指南对稳定性、工艺验证和分析方法...
productsare designed and developed in accordance with the requirements of this documentand other associated guidelines such as good laboratory practice (GLP)(3), good clinical practice (GCP)(2)and good storage and distributionpracti...
productsare designed and developed in accordance with the requirements of this documentand other associated guidelines such as good laboratory practice (GLP)(3), good clinical practice (GCP)(2)and good storage and distributionpractices (GSDP)(4), whereappropriate; ...
productsare designed and developed in accordance with the requirements of this documentand other associated guidelines such as good laboratory practice (GLP) (3), good clinical practice (GCP) (2)and good storage and distributionpractices (GSDP)(4), whereappropriate; ...
1.1. In recent years, the number ofobservations made regarding the integrity of data, documentation and recordmanagement practices during inspections of good manufacturing practice (GMP) (2),good clinical practice (GCP), good laboratory practice (GLP) and Good Trade andDistribution Practices (GTDP)...
productsare designed and developed in accordance with the requirements of this documentand other associated guidelines such as good laboratory practice (GLP) (3), good clinical practice (GCP) (2)and good storage and distributionpractices (GSDP)(4), whereappropriate; ...