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...
你们的回复是不充分的,因为你们没有讨论对流通中已经生产而未经适当稳定性测试的 API 批次的回顾性审查。 Without an adequate stability program, you cannot ensure that your APIs meet established specifications and all pre-determined...
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...
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...
FDA approves shelf-life increaseReports on the US Food and Drug Administration's approval of the shelf-life for a liposomal doxorubicin by Sequus.Dermatology Times
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。
he U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Clientele, Inc., FEI 3012481086, at 14101 NW 4th Street, Sunrise, Florida, from February 3 to 7, 2020. 2020年2月3日至7日,美国FDA检查了你们的药品生产设施Clientele, Inc.,FEI 3012481086,位于佛罗里达州(详...
(reuters) -the u.s. food & drug administration extended the shelf life for johnson & johnson's single-shot covid-19 vaccine to six months from four-and-a-half months, the company said late wednesday. the fda's decision is based on data from ongoing studies,...
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 o Detailed definition of the specific attributes to be tested at each station (timepoint) ...
18 For further information on our requirements for the minimum quantity of dietary ingredients throughout the shelf life of a dietary supplement, see 21 CFR 101.9(g)(3) and (g)(4), and 101.36(f)(1). 19 Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration,...