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? 1.03K viewsFDA 0 Votes 1 Ans Is there an acceptable substitute for dioctyl phtalate (DOP) to integrity testing of high-efficiency particulate air (HEPA) filters? 1.19K 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? 1.23K 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? 1.08K viewsFDA 0 Votes 1 Ans What should be the standard of compressed air used in the manufacture of a drug? 1.11K 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? 1.15K viewsFDA 0 Votes 1 Ans Should equipment be labelled with calibration dates? 1.35K viewsFDA 0 Votes 1 Ans What are the The key differences between a US Agent and an Official Correspondent? 1.27K viewsFDA 0 Votes 1 Ans Can Emergo act as your Official Correspondent and US Agent? 1.22K viewsFDA 0 Votes 1 Ans How do I establish a sampling plan for in-process testing and finished product release? 1.21K viewsFDA 0 Votes 1 Ans When is retesting appropriate? 1.23K viewsFDA 0 Votes 1 Ans Is sample storage and handling important? 1.22K viewsFDA 0 Votes 1 Ans Can finished product samples for analysis of bacterial endotoxins be pooled into a composite sample prior to analysis? 1.28K viewsFDA 0 Votes 1 Ans May a firm use alternative assays to those in the USP for a compendial article? 1.13K viewsFDA 0 Votes 1 Ans What is the best process for transitioning from one alternate bacterial endotoxins test (BET) method to another? 1.09K viewsFDA 0 Votes 1 Ans What happened to the endotoxins limit table in Appendix E of the 1987 Guidance? 957 viewsFDA 0 Votes 1 Ans How can Quality by Design concepts support endotoxins limits? 1.21K viewsFDA 0 Votes 1 Ans When is the USP Chapter <151> Pyrogenicity Test (the rabbit pyrogen test) appropriate? 1.05K viewsFDA 0 Votes 1 Ans How would an appropriate endotoxins limit be determined for a veterinary product that targets multiple species? 890 viewsFDA 0 Votes 1 Ans What are the endotoxins limits for medical devices? 1.13K viewsFDA « Previous 1 2 … 197 198 199 200 201 … 283 284 Next » Question and answer is powered by anspress.net
