Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Have U.S. manufacturers of potassium iodide been asked to ship any products to Japan? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a sponsor of an investigational new drug export its product to Japan? Does FDA have to authorize such an export? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to all of the analytical support work conducted to provide supplementary data to a safety study? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections? does FDA perform and how frequently are they done? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans For drug products formulated with preservatives to inhibit microbial growth, is it necessary to test for preservatives as part of batch release and stability testing? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the benefits of implementing a pharmaceutical quality system (PQS) (in accordance with ICH Q10)? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans How does a company demonstrate implementation of PQS in accordance with ICH Q10? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans How will product-related inspections differ in an ICH Q8, Q9 and Q10 environment? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans How will system-related inspections differ in an ICH Q8, Q9, and Q10 environment? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about drug contamination with halogenated anisole compounds, such as 2,4,6-tribromoanisole (TBA)? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA identified the source of the halogenated anisole compounds that have contaminated drug products? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans What is FDA’s expectation for preventing contamination of drug products with halogenated anisole compounds? 1.31K viewsDrugsPharmaceutical 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? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Can FDA mandate a recall of human drugs? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Do manufacturers of OTC products have to report quality defects? 1.53K 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? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans FDA withdrew its draft guidance for industry on Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment. What were the Agency’s major concerns with this guidance? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about proper sampling of powder blends? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans What are some recommended innovative approaches to ensuring adequacy of mixing of powder blends? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the Agency’s recommendations regarding in-process stratified sampling of finished dosage units? 1.61K viewsDrugsPharmaceutical « Previous 1 2 … 12 13 14 15 16 … 79 80 Next » Question and answer is powered by anspress.net
