Adding to the concern: the profusion of ultra-processed foods, which use a wide array of chemicals to add flavor and color, extend shelf life, reduce cost, control texture or consistency, and generally tempt people to eat more. Ultra-processed foods now make up 73% of the U.S. food s...
FDA警告信:承诺的CAPA,为何不执行? 10月6日,FDA公布一封针对加拿大企业的警告信。主要的违规项涉及:设备系统存在问题、未能执行工艺和清洁验证,缺乏适当的稳定性数据,未能验证供应商CoA的可靠性。 在该警告信中, FDA特别指出: 此前FDA已经对该公司进行了检查,公司承诺...
许多CGT产品需要冷冻储存相当长的时间。在强制条件(stress conditions)下进行的加速稳定性研究可能有助于确定稳定性指示属性,但保质期(shelf life)应基于在长期储存条件下获得的实时稳定性数据(real-time stability data)。生成实时长期稳定性数据可能会延迟产品开发,尤其是在产品开发后期实施可能对稳定性产生不利影响的生...
2020年12月29日,FDA公布一封针对美国本土企业(Clientele, Inc.)的警告信。主要的违规项涉及工艺验证不充分、水系统和稳定性问题。 FDA重点指出,该公司的质量单元存在重大问题,未能履行其相关职责。为此,公司承诺停止生产药品,并注销其药品生产商的资格。 Dear Ms. Ril...
The Food and Drug Administration (FDA) extended the Johnson & Johnson COVID-19 vaccine’s shelf life on Wednesday to six months amid state officials’ concerns of expiring doses. The federal agency approved an amendment to Johnson & Johnson’s emergency use authorization to allow its single-dos...
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wuhu Nuowei Chemistry Co., Ltd., FEI 3014438694, at Xuancheng 323 Provincial Road, Pang, Jingde, Xuancheng, from September 2 to 6, 2024. 美国食品药品监督管理局(FDA)于2024年9月2日至6日对贵公司位于XXX...
The Food and Drug Administration (FDA) has extended the shelf life of the Johnson & Johnson COVID-19 vaccine by a month and a half, a move that helps ease concerns about doses that would soon expire. The FDA said the shelf life is now 4 1/2 months inste
The FDA labs in Detroit and San Juan had also been responsible for checking the shelf life of medical treatments stockpiled by the federal government for the military and pandemics, under a program administered by the Department of Defense. The layoffs also cut chemists based out of the labs ...
在强制条件(stress conditions)下进行的加速稳定性研究可能有助于确定稳定性指示属性,但保质期(shelf life)应基于在长期储存条件下获得的实时稳定性数据(real-time stability data)。生成实时长期稳定性数据可能会延迟产品开发,尤其是在产品开发后期实施可能对稳定性产生不利影响的生产变更时。对于许可后的生产变更,可能...
o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid 正在进行的计划,每年将每种产品的代表性批次添加到其中,以确定有效期声明是否仍然有效