Here is a sample FDA software validation template: Master Validation Plan: Outlines the scope of the validation project and the strategy for validating the software’s installation and use. Includes an overview of each process, the validation approach and the rationale for following it. Design Quali...
For more than three decades, FDA has claimed that the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here). In this post, we summarize the purported basis for this claim...
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigat...
Please provide an update on these corrective actions and your plan to address the inadequacy of your justification for assignment of a severity score of (b)(4) for Complaint 263736. 根据企业的回复,CAPA CA-00068于2021年6月25日启动。完成了根本原因分析,并对随机选择的投诉进行了审查,得出损害和...
GMP system standard operating procedures must be based on current Good Manufacturing Practice expectations to demonstrate compliance and to succeed to any upcoming regulatory inquiry like an inspection from theFood and drug Administration (FDA)or from theEuropean Medicine Agency (EMA)or any other heath...
On Friday, August 25, 2023, FDA released a much-anticipated Final Guidance titled,“Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act,”addressing FDA’s implementation of certain electronic interoperability provisions of theDrug Sup...
The U.S. Food and Drug Administration found asbestos in a bottle of Johnson’s Baby Powder in 2019. This report forced the company to issue a recall of the batch associated with the contaminated bottle. Additional Talc Products Containing Asbestos Talc products containing asbestos have included ...
Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in their coordinated regulation of biotechnology products. Consistent with a directive issued by President Biden in September 2022, the agencies’ plan identifies specific issues that each ...
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials. These drugs, ...