Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Do the GLPs apply to all of the analytical support work conducted to provide supplementary data to a safety study? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections does FDA perform and how frequently are they done? 979 viewsDrugsPharmaceutical 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 928 viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements for labeling of reagents purchased directly from manufacturers? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA paying special attention to injectable and inhalable drugs? 905 viewsDrugsPharmaceutical 0 Votes 1 Ans What are the FDA approved products for treatment of internal contamination with radioactive iodine? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Is potassium iodide the only medication available for radiation exposure? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans We have heard that potassium iodide is in short supply. Is that correct? 961 viewsDrugsPharmaceutical 0 Votes 1 Ans Can FDA mandate a recall of human drugs? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans What should a firm do if its drug products or components have been subjected to improper storage conditions such as those caused by a natural disaster? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Do manufacturers of OTC products have to report quality defects? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Is this okay? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the CGMP regulations permit the destruction of an internal quality assurance audit report once the corrective action has been completed? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be considered in performing an assessment of whether a firm’s drug product, or its components or packaging materials may have been contaminated with radioactive material? 906 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Does equipment need to be clean enough to meet limits based on the most sensitive possible methods of residue detection or quantification? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans What is FDA’s expectation for preventing contamination of drug products with halogenated anisole compounds? 1.27K viewsDrugs 0 Votes 1 Ans Many leading analytical balance manufacturers provide built-in “auto-calibration” features in their balances. Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be? 1.20K viewsDrugsPharmaceutical « Previous 1 2 … 78 79 80 Question and answer is powered by anspress.net
