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? 1.33K 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? 1.39K 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? 1.23K viewsFDA 0 Votes 1 Ans What should be the standard of compressed air used in the manufacture of a drug? 1.37K 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? 1.30K viewsFDA 0 Votes 1 Ans Should equipment be labelled with calibration dates? 1.51K viewsFDA 0 Votes 1 Ans What are the The key differences between a US Agent and an Official Correspondent? 1.43K viewsFDA 0 Votes 1 Ans Can Emergo act as your Official Correspondent and US Agent? 1.37K viewsFDA 0 Votes 1 Ans How do I establish a sampling plan for in-process testing and finished product release? 1.35K viewsFDA 0 Votes 1 Ans When is retesting appropriate? 1.56K viewsFDA 0 Votes 1 Ans Is sample storage and handling important? 1.39K viewsFDA 0 Votes 1 Ans Can finished product samples for analysis of bacterial endotoxins be pooled into a composite sample prior to analysis? 1.42K viewsFDA 0 Votes 1 Ans May a firm use alternative assays to those in the USP for a compendial article? 1.29K viewsFDA 0 Votes 1 Ans What is the best process for transitioning from one alternate bacterial endotoxins test (BET) method to another? 1.30K viewsFDA 0 Votes 1 Ans What happened to the endotoxins limit table in Appendix E of the 1987 Guidance? 1.14K viewsFDA 0 Votes 1 Ans How can Quality by Design concepts support endotoxins limits? 1.36K viewsFDA 0 Votes 1 Ans When is the USP Chapter <151> Pyrogenicity Test (the rabbit pyrogen test) appropriate? 1.26K viewsFDA 0 Votes 1 Ans How would an appropriate endotoxins limit be determined for a veterinary product that targets multiple species? 1.04K viewsFDA 0 Votes 1 Ans What are the endotoxins limits for medical devices? 1.30K viewsFDA 0 Votes 1 Ans What is the FDA’s expectation for regular screening of therapeutic drug products? 1.29K viewsFDA « Previous 1 2 … 51 52 53 54 55 … 75 76 Next » Question and answer is powered by anspress.net
