FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is there an acceptable substitute for dioctyl phtalate (DOP) to integrity testing of high-efficiency particulate air (HEPA) filters? 1.28K viewsFDA 0 Votes 1 Ans What is the acceptable limit for dew point of the compressed air used in pneumatic equipment and to dry the manufacturing tanks after cleaning? 1.33K viewsFDA 0 Votes 1 Ans What are the requirements applicable to Quality Control (QC) and engineering personnel who travel many times daily between self-contained facilities and the regular facilities? 1.19K viewsFDA 0 Votes 1 Ans What should be the standard of compressed air used in the manufacture of a drug? 1.30K viewsFDA 0 Votes 1 Ans Does the concept of self-contained facilities apply equally to research and development laboratories (susceptible to contain highly sensitizing, highly potent or potentially pathogenic material in the analytical scale) that may be in the same building as the manufacturing facilities, or is this concept limited to actual manufacturing operations? 1.26K viewsFDA 0 Votes 1 Ans Should equipment be labelled with calibration dates? 1.46K viewsFDA 0 Votes 1 Ans What are the The key differences between a US Agent and an Official Correspondent? 1.38K viewsFDA 0 Votes 1 Ans Can Emergo act as your Official Correspondent and US Agent? 1.31K viewsFDA 0 Votes 1 Ans How do I establish a sampling plan for in-process testing and finished product release? 1.30K viewsFDA 0 Votes 1 Ans When is retesting appropriate? 1.46K viewsFDA 0 Votes 1 Ans Is sample storage and handling important? 1.33K viewsFDA 0 Votes 1 Ans Can finished product samples for analysis of bacterial endotoxins be pooled into a composite sample prior to analysis? 1.37K viewsFDA 0 Votes 1 Ans May a firm use alternative assays to those in the USP for a compendial article? 1.23K viewsFDA 0 Votes 1 Ans What is the best process for transitioning from one alternate bacterial endotoxins test (BET) method to another? 1.22K viewsFDA 0 Votes 1 Ans What happened to the endotoxins limit table in Appendix E of the 1987 Guidance? 1.07K viewsFDA 0 Votes 1 Ans How can Quality by Design concepts support endotoxins limits? 1.31K viewsFDA 0 Votes 1 Ans When is the USP Chapter <151> Pyrogenicity Test (the rabbit pyrogen test) appropriate? 1.20K viewsFDA 0 Votes 1 Ans How would an appropriate endotoxins limit be determined for a veterinary product that targets multiple species? 992 viewsFDA 0 Votes 1 Ans What are the endotoxins limits for medical devices? 1.24K viewsFDA 0 Votes 1 Ans What is the FDA’s expectation for regular screening of therapeutic drug products? 1.22K viewsFDA « Previous 1 2 … 51 52 53 54 55 … 75 76 Next » Question and answer is powered by anspress.net
