Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Where do gases fall, i.e., nitrogen for the blanket, as a raw material or process aid? Do they require material management control, quarantine, ID testing, etc? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Covid vaccine stop you getting Covid? 1.03K viewsCOVID-19 0 Votes 1 Ans What countries are vaccinating for Covid? 1.20K viewsCOVID-19 0 Votes 1 Ans Who is at risk for coronavirus? 1.20K viewsCOVID-19 0 Votes 1 Ans Are you immune to COVID-19 if you get it once? 1.31K viewsCOVID-19 0 Votes 1 Ans Why should people wear masks during the COVID-19 pandemic? 1.30K viewsCOVID-19 0 Votes 1 Ans What is Bedoyecta used for? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Under Section 7.3, third paragraph, “describe other special materials.” These are materials excluded from testing. Does the company define the special materials? If so, on what basis? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an appropriate system to allow a material’s use while still under quarantine? What makes a conditional release appropriate? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans When incoming materials are mixed with existing stocks, for example, solvents. How can a distinctive batch or receipt number be meaningful for purposes of tracking materials used in a specific production batch? And, how useful is assigning batch numbers to such materials when they are mixed? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Is black ink pen, which looks like photocopying, acceptable for filling in data in batch records? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Equipment cleaning and use records. For multi-use, non-dedicated equipment, is it acceptable to have these records as part of the batch record or is a separately maintained record required. 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the section on equipment cleaning and use records (section 6.2) apply to lab equipment in the laboratory. For example, HPLCs, balances, GCs, etc.? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans For an existing registered process, is the starting material listed in the drug master file registration the starting material for Q7A?” 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Control data requests that you retain data on the preparation and testing of reference standards. Since many of the reference standards are purchased, how can one accomplish this? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it appropriate in a batch record to have large spaces, i.e., pages, for handwritten comments to be entered to document observations, etc., as well as spaces for entering data, i.e., tables. 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Does every operation in a critical step automatically become subject to QA record review? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans If an API has an impurity, does the dosage form manufacturer have the responsibility to identify it if the API manufacturer provides a C of A? Which of the two does FDA hold legally responsible? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a batch numbering system need to be sequential? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans Do isolated synthetic intermediates intended for use in the next process step need to be quarantined and released by the quality unit? 1.64K viewsDrugsPharmaceutical « Previous 1 2 … 51 52 53 54 55 … 283 284 Next » Question and answer is powered by anspress.net
