While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiterated by many participants. Given the complexities relating to post-approval changes...
For changes to an Innovator or Multisource (Generic) FPP Prequalified on the basisof SRA approval, please refer to SRA-approved Multisource (generic) or Innovator FPPs. The timelines are subject to change and will be updated, as and when appropriate. Whenever there is conflict, the timeline ...
When changes are made to any result or data, the change should be traceable to the person who made the change, the date, time and reason for the change. In electronic systems, this traceability should be documented via computer generated audit trails or in other metadata fields or system fea...
When changes are made to any result or data, the change should be traceable to the person who made the change, the date, time and reason for the change. In electronic systems, this traceability should be documented via computer generated ...
Transfer of processes to an alternative site occurs at some stage in the life-cycle of most products, from development, scale-up, manufacturing, production and launch, to the post-approval phase. 将工艺转移至一个可替代的场所发生在大多数产品的生命周期的某些阶段,从研发、放大、生产、到 上市后...
The World Health Organization (WHO) released in 2020 updated global guidelines on physical activity and sedentary behaviour for children, adolescents, adults, older adults and sub-populations such as pregnant and postpartum women and those living with ch
Although data regarding changes in pharmacotherapy and relapse were obtained prospectively, it is possible that depressive relapse had begun before the discontinuation of the antidepressant. Nonetheless, our findings help to refine the risk-benefit decision for those women with major depression who are ...
3、ocus has been placed on the quality aspects, in l ine with WHO s mandate.1.1 Transfer of processes to an alternative site occurs at some stagein the life-cycle of most products, from development, scale-up, manufactur ing, producti on and launch, to the post-approval phase.1.2 Transfe...
ensuring segregation of duties; 规定进入GxP 自动化和计算机化系统的访问和权限,确保职责分离; ensuring audit trail activation for all interactions and restricting the ability to enable or disable audit trails (Note: ‘back-end’ changes and ‘hard’ changes, such as hard deletes, should ...
development, manufacturing and control; clinical trials or monitoring post licensure. Their utility is envisioned not only in light of the global strategy for cervical cancer elimination, but also in serological investigations of other HPV-related diseases and natural infections in both women and men....