Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does GDUFA make any changes to traditional definitions of API and FDF manufacturers? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Are all facilities, sites, and organizations listed above also required to pay facility fees? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is required to pay facility fees? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the penalty for failure of a facility to pay a facility fee or self-identify? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Do two locations of the same company have to identify separately? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What is compounding, and why is it necessary? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans How is pharmaceutical compounding different from drug manufacturing? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a compounding pharmacy? 925 viewsDrugsPharmaceutical 0 Votes 1 Ans Who regulates compounding pharmacies? Do compounding pharmacies follow the same regulations as drug manufacturers? Why or why not? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans How would patients know if their medication is compounded? Knowing that, should they take any precautions, or do anything differently? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a compounding pharmacist have special training? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans When is a compounding pharmacy necessary? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Where is more information about compounding available? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans What caused the meningitis outbreak, and how could it have been prevented? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Will the outbreak lead to reconsideration of or changes in current policy/regulations? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Can electronic copies be used as accurate reproductions of paper or electronic records? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to retain paper printouts or static records instead of original electronic records from stand-alone computerized laboratory instruments, such as an FT-IR instrument? 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans Can electronic signatures be used instead of handwritten signatures for master production and control records? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans When does electronic data become a CGMP record? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Why has the FDA cited use of actual samples during “system suitability” or test, prep, or equilibration runs in warning letters? 1.21K viewsDrugsPharmaceutical « Previous 1 2 … 28 29 30 31 32 … 79 80 Next » Question and answer is powered by anspress.net