Mock C. WHO releases Guidelines for trauma quality improvement pro- grammes. Inj Prev: J Int Soc Child Adolesc Inj Prev 2009;15(Oct (5)):359.Mock C. WHO releases Guidelines for trauma quality improvement progra
2.6. The WHO document titled Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans (1) specifically addresses the requirements and recommendations for products used in clinical trials. Other WHO ...
12.16. The quality target product profile, critical quality attributes, critical process parameters, material attributes, control strategy and any other impacting elements on the quality of the product should be available. (See also ICH guidelines....
New WHO air quality guidelines are being developed to address these issues. Aims: To address the above questions drawing on evidence from new evidence reviews conducted for the WHO guidelines. Methods: Discussion of key findings from reviews covering (i) systematic reviews of health risks from HAP...
12月4日,世界卫生组织(WHO)于发布《药品生产技术转移指南》(WHO guidelines on the transfer of technology in pharmaceutical manufacturing),提供了药品技术转让期间应考虑的指导原则。 WHO最新指南:《药品生产技术转移指南》(中英文对照) PharmLink指南组 蒲公英 今天 12月4日,世界卫生组织(WHO)于发布《药品生产技术...
Risk management principles, as described in other WHO guidelines on quality risk management (10), should be applied to assist in identifying risks and controls to mitigate contamination and cross-contamination. 应使用风险管理原则来帮助确定风险和控制以减少污染和交叉污染。
Resulting data and evidence from digital implementations inform iterative cycles of improvement. The first knowledge layer (L1: Narrative layer—enhanced guidelines) represents traditional guidelines and guidance, and details how the current guideline development process can be enhanced to better support ...
They have been aligned to the extent possible with the terminology in related WHO guidelines and good practices included in the WHO Quality Assurance of Medicines Terminology Database – List of Terms and related guidelines.⁵ But may have different meanings in other contexts.下述定义适用于本文件...
Riskmanagementprinciples,asdescribedbyWHOandotherguidelinesonqualityriskmanagement(10),shouldbeappliedtoassistinidentifyingand assessingrisks.Theappropriatecontrolsshouldbeidentifiedandimplementedtomitigatecontaminationandcross-contamination. 应使⽤风险管理原则,如WHO其他质量风险管理指南(10)所述,以帮助确定评估风险。应...
4.4. The quality system should ensure that: 质量体系应确保: 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 ...