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...
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 ...
On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, wasintroduced. This legislation, named theInnovative Feed Enhancement and Economic Development Act (Innovative FEED Act), is an effort to create an approval process f...
Talcum powder is the most widely used consumer talc product. Asbestos in talc could increase the risk of mesothelioma.
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...
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...
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, ...