一共三个发现项,比较有意思的是第一条。 You produced hazardous drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination. 你在没有提供足够的隔离、工作表面清洁和器具清洁以防止交叉污染的情况下生产了危害性药物。 西门的备注: 危害性药物...
D. Reagents A list of reagents and their grades (., USP/NF, American Chemical Society (ACS) Analytical Reagent) should be included. If in-house or modified commercial reagents are used, directions for their preparation should be included. Unstable or potentially hazardous reagents should be ...
With PIC/S, both sides are able to see and use a master list of over 2,300 planned inspections planned by PIC/S members, and FDA and Health Canada are informed of each other’s schedule of foreign inspections. FDA and Health Canada will explore the possibility of performing joint inspectio...
If a cosmetic contains triclosan, it will be included in the ingredient list on the product label. 除菌皂、沐浴露以及牙膏属于非处方药,若含有三氯生,则会在标签上的“药物成分”栏列出;如果化妆品中含有三氯生,则会在产品的成分表上列出。 What is FDA doing to evaluate the safety of triclosan?
美国FDA分析方法验证指南中英文对照四美国FDA分析方法验证I. INTRODUCTIONThis guidance provides recommendations to applicants on submitting analytic
and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found inJohnson & Johnson’s Annual Report on Form 10-K for the fiscal...
D. Reagents A list of reagents and their grades (e.g., USP/NF, American Chemical Society (ACS) Analytical Reagent) should be included. If in-house or modified commercial reagents are used, directions for their preparation should be included. Unstable or potentially hazardous reagents should be...
List of products not FDA Approved #1. US FDA does not approve Health care providers, including physician offices, or laboratories #2. Compounded drugs are not FDA approved. #3. The transplantation of vascularized human organ transplants, such as kidney, liver, heart, lung, or pancreas, is no...
List of products not FDA Approved #1.US FDA does not approve Health care providers, including physician offices, or laboratories #2.Compounded drugs are not FDA approved. #3.The transplantation of vascularized human organ transplants, such as kidney, liver, heart, lung, or pancreas, is not su...
* Roles/Tasks (--short list) Pose the risk question. Charge the Risk Assessors with the Risk Assessment Task. Convene stake holders. Analyze decision options. Make/recommend the decision. Identify data and gather information on the nature, extent, magnitude and uncertainty of the risk. Write ...