Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans How long does FDA allow a laboratory to effect corrective actions after an inspection has been made? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA established guidelines for the frequency of calibration of equipment (balances) used in nonclinical laboratory studies? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the GLP requirements for labeling of reagents purchased directly from manufacturers? 1.56K 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 Based on FDA changing of the meaning of “should”, does this mean that Q7A will be applied differently in the US than in the EU? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you define a “significant structural element” in an API starting material? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans How close can you get to the API and still call it an API starting material? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans How early should a company discuss with FDA the company strategy, rationale and what we consider to be an API starting material for filing? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans If you identify an API starting material vendor, does that vendor need to be audited or qualified? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Are internal audit reports mentioned in Section 2.4 subject to FDA review during an inspection? 1.63K viewsDrugsPharmaceutical 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? 1.62K 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? 1.48K 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? 1.48K 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? 1.59K 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? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Why FDA paying special attention to injectable and inhalable drugs? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the FDA-approved products for treatment of internal contamination with radioactive iodine? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Is potassium iodide the only medication available for radiation exposure? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans We have heard that potassium iodide is in short supply. Is that correct? 1.48K viewsDrugsPharmaceutical « Previous 1 2 … 11 12 13 14 15 … 79 80 Next » Question and answer is powered by anspress.net
