Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Are firms required to use high-efficiency particulate air (HEPA) filters for air supply in areas used for the manufacture of non-sterile dosage forms? 1.07K viewsFDA 0 Votes 1 Ans Is there an acceptable substitute for dioctyl phtalate (DOP) to integrity testing of high-efficiency particulate air (HEPA) filters? 1.23K 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? 1.27K 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? 1.13K viewsFDA 0 Votes 1 Ans What should be the standard of compressed air used in the manufacture of a drug? 1.19K 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? 1.20K viewsFDA 0 Votes 1 Ans Should equipment be labelled with calibration dates? 1.40K viewsFDA 0 Votes 1 Ans What are the The key differences between a US Agent and an Official Correspondent? 1.31K viewsFDA 0 Votes 1 Ans Can Emergo act as your Official Correspondent and US Agent? 1.26K viewsFDA 0 Votes 1 Ans How do I establish a sampling plan for in-process testing and finished product release? 1.25K viewsFDA 0 Votes 1 Ans When is retesting appropriate? 1.35K viewsFDA 0 Votes 1 Ans Is sample storage and handling important? 1.28K viewsFDA 0 Votes 1 Ans Can finished product samples for analysis of bacterial endotoxins be pooled into a composite sample prior to analysis? 1.32K viewsFDA 0 Votes 1 Ans May a firm use alternative assays to those in the USP for a compendial article? 1.17K viewsFDA 0 Votes 1 Ans What is the best process for transitioning from one alternate bacterial endotoxins test (BET) method to another? 1.13K viewsFDA 0 Votes 1 Ans What happened to the endotoxins limit table in Appendix E of the 1987 Guidance? 1.01K viewsFDA 0 Votes 1 Ans How can Quality by Design concepts support endotoxins limits? 1.25K viewsFDA 0 Votes 1 Ans When is the USP Chapter <151> Pyrogenicity Test (the rabbit pyrogen test) appropriate? 1.11K viewsFDA 0 Votes 1 Ans How would an appropriate endotoxins limit be determined for a veterinary product that targets multiple species? 932 viewsFDA 0 Votes 1 Ans What are the endotoxins limits for medical devices? 1.18K viewsFDA « Previous 1 2 … 197 198 199 200 201 … 283 284 Next » Question and answer is powered by anspress.net
