Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Also, no log is kept of the raw materials sampled. Is this acceptable? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Do distributors of raw materials need to be approved and put on an approved supplier list? What is needed? Is an audit needed? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Does three-batch testing of raw material have to include all tests listed on the supplier Certificate of Analysis? If your company’s specifications do not include all of those listed by the supplier, would it be acceptable to test to you specifications? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans May raw materials delivered in tankers be mixed in silos with old batches of the very same raw material after a limited ID testing is performed? Date and time of mixing and identity are, of course, well known. 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Are we expected to QC release polybags, drums and containers and plastic scoops used to scoop and sample APIs? 1.26K 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? 1.32K 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? 1.51K 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? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans For a non-dedicated tanker, if a Certificate of Cleaning is utilized to ensure no cross contamination, does verification of cleaning need to be performed? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans What type of laboratory controls and testing are typically expected of labels and secondary packaging containers? Is visual inspection sufficient? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to physically separate the rejected material or is labeling sufficient? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need separate areas for materials in quarantine or under test? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you validate a method for a toxic or a very dangerous raw material? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to audit a supplier? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans There is no specific definition for critical raw material. Should we combine the definition for raw material and the definition for critical to come up with the criteria? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Why aren’t bulk deliveries of chemicals used in API manufacturing held to the same standards as APIs? There is no validation of clean outs for non-dedicated tankers. 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Is statistical sampling a lot for raw materials used for production of APIs sent to Europe? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between evaluating suppliers of critical material in Section 7.1, and the supplier approval evaluation discussed in Section 7.3? Does Section 7.3 pertain to all materials or just critical materials? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Sampling and testing states that, “No testing necessary for special materials if . . .” Please define special materials in this context. 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding Alternate method for rejected material, is it okay not to have a separate area? 1.66K viewsDrugsPharmaceutical « Previous 1 2 … 50 51 52 53 54 … 283 284 Next » Question and answer is powered by anspress.net
