而存储寿命，或称为设备的保质期，指的是在未启用状态下设备保持性能的时间。需注意的是，FDA对设备的"Shelf Life"（存储寿命）规定与国内的理解可能存在差异。FDA的指导原则，如"Medical Devices Shelf Life Guidance"，重点是确保设备在整个预期存储期限内的性能稳定，这通常借鉴了无源产品（整机不开机）...
Shelf life of the device:储存时间或服务时间 注意和国内的说法区分 FDA的指南: Shelf Life of Medical Devices | FDA Summary of methods used to establish that device performance is maintained for the entirety of the proposed shelf-life according to the "Guidance for Shelf Life" and product design ...
12. Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, January 2011, https://www.fda.gov/media/79856/download. 13. Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry, July 2015, https://www.fda.gov/media/87801/download. *When ...
调查不充分可能导致无法确定根本原因、无效的纠正措施和预防措施 (CAPA) 以及影响生产安全有效药物能力的反复出现的问题。 For more information about handling OOS results and documentation of your investigations, please refer to the ...
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
See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www./media/71023/download. ...
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...
3. Guidance for Industry: Q8(R2) Pharmaceutical Development, November 2009,https://www.fda.gov/media/71535/download. 4. Guidance for Industry: Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products, April 1996,https://www.fda.gov/regulatory-in...
Data for (b)(4) batches successfully manufactured as part of prospective qualification studies, to demonstrate that these batches are stable over the shelf life. 作为前瞻性确认研究的一部分的XX批次成功生产的数据,以证明这些批次在货架期内是稳定性 ...
See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. 请参阅FDA的指南《工艺验证:一般原则和实践》,就FDA考虑的工艺验证适当要素,获取...