Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How often do I need to change my password in FURLS? 1.41K viewsFDA 0 Votes 2 Ans What is a clinical trial? 1.85K viewsFDA 0 Votes 1 Ans There is no expectation in Q7A to have to audit starting material suppliers. It was also stated that starting material suppliers should be qualified. Does this mean that vendor qualification does not need to include an audit? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans If Q7A does not apply to API starting materials, is it necessary or mandatory to, first of all, audit manufacturers of API starting materials? And B, if an API manufacturer decides to audit the manufacturers starting materials, against which document should the audit be conducted? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a recall? 1.62K viewsFDA 0 Votes 1 Ans Are OTC drugs subject to the same recall provisions as prescription drugs? 1.36K viewsFDA 0 Votes 1 Ans What happens if a firm does not voluntarily recall a defective product? 1.50K viewsFDA 0 Votes 1 Ans Do CGMPs require that forced degradation studies always be conducted of the drug product when determining if a drug product stability test method is stability-indicating? 1.55K viewsFDA 0 Votes 1 Ans When performing the USP <788> Particulate Matter in Injections test for a Large Volume Parenteral (LVP), is it acceptable to take the average among the units tested to determine if the batch meets its specification for this attribute? 1.74K viewsFDA 0 Votes 1 Ans Would a paramagnetic or laser oxygen analyzer be able to detect all possible contaminants or impurities in a medical gas? 1.66K viewsFDA 0 Votes 1 Ans Are there any challenges with facilities complying with global cGMP regulations? 1.66K viewsFDA 0 Votes 1 Ans In which intervals do systems have to be validated? 1.64K viewsFDA 0 Votes 1 Ans Is it necessary to approve hardware and software suppliers formally? 1.53K viewsFDA 0 Votes 1 Ans What is standard software? Does standard software have to be validated? 1.73K viewsFDA 0 Votes 1 Ans Traceability matrix – what is necessary? Must an end user have a traceability matrix, administrate it and validate it? 1.60K viewsFDA 0 Votes 1 Ans Which significance do the PIC/S Guidances have? 1.64K viewsFDA 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? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you do an ID test, such as IR, on polyethylene bags for API packaging, or could you rely on vendor label ID? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans If a material is received from another site within your own company, say a site in another state, do you need to perform an ID test of the material upon receipt? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the expectation for auditing and qualifying a producer of an API starting material from a manufacturer of material made for both industrial and API applications? 1.60K viewsDrugsPharmaceutical « Previous 1 2 … 260 261 262 263 264 … 283 284 Next » Question and answer is powered by anspress.net
