Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Concerning the distinction that you made between ICH versus VICH for APIs for veterinary products, which standards do the FDA inspectors use in the plants producing APIs for US vet products? Are there any differences seen during a PAI, and which standards should a plant follow? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans You said that the WHO has now decided to compare the Q7A document with its 1992 API GMPs., I heard previously that the WHO was adopting Q7A with no mention of this evaluation. Is this just a standard procedural issue at WHO or do they have specific concerns, doubts, problems with Q7A? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans To my knowledge, China, Australia, and India have not had official (observer or participant) status in previous ICH guidance processes. By participating in Q7A, do they agree to be bound by it? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA established guidelines for the frequency of calibration of equipment (balances) used in nonclinical laboratory studies? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Have U.S. manufacturers of potassium iodide been asked to ship any products to Japan? 1.62K 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? 1.66K 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? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections does FDA perform and how frequently are they done? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements for labeling of reagents purchased directly from manufacturers? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FDA reject nonclinical laboratory studies that have not been conducted in full compliance with the GLPs? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA paying special attention to injectable and inhalable drugs? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the FDA approved products for treatment of internal contamination with radioactive iodine? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Is potassium iodide the only medication available for radiation exposure? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans We have heard that potassium iodide is in short supply. Is that correct? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Can FDA mandate a recall of human drugs? 1.57K 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? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Do manufacturers of OTC products have to report quality defects? 1.49K 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? 1.68K viewsDrugsPharmaceutical « Previous 1 2 … 78 79 80 81 82 83 Next » Question and answer is powered by anspress.net
