Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If the requirements for traceability and quality specifications for an API are so critical, then why is Q7A only guidance without the weight of a regulation in the U.S.? Are there any plans for implementation of these regulations into an actual regulation in the future? If not, why not? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you provide a definition of adulteration in terms of Q7A, for example, if a rubber band falls into a tank at the beginning of a process and can be removed and shown to have lost no extractables and not impacted product quality, is it adulteration? Can removal be considered a deviation or reprocessing? 965 viewsDrugsPharmaceutical 0 Votes 1 Ans For rework and reprocessing, Part 211 requires changing batch numbers to make it evident that the batch has been reprocessed/reworked. Is this still a requirement for APIs under Q7A? It’s very burdensome when reprocessing occurs based on in-process testing. 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans If you subject the final API to reworking with a different solvent, where do you draw the line between being in compliance with GMPs and being out of compliance from a regulatory standpoint? Would you need to update your certificate of analysis to test for the additional solvent and notify the drug manufacturer of the reworked batch? If not, why? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans For material that has reached its retest date, what is the generally accepted length of time the retested material can be distributed for commercial use past that date? Evidently, they mean you retest it at that date, it passes, and it looks okay, still hits specs. How long can you redistribute that material? Do you have to establish a new retest date? What procedure do you use to do that? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to re-validate the same re-crystallization step for different reasons for reprocessing? For physical contamination? For out-of-spec particle size? For out-of-spec LOD? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Reprocessing need to be validated and, if so, is concurrent release appropriate? Then, the statement is made that this practice could result in validation packages remaining open for long periods of time. Why don’t you address that, and there are a couple of other twists I can throw in if you don’t have enough fun with that one. 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Would a solvent recovered as an azeotrope for use in the same process be required to be tested before its re-use according to Section 14.4, especially if this is from a continuous process? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it permissible to have an optional reprocessing step, for example a re-slurry, as part of the manufacturing instructions, where the decision on whether or not to reprocess would be based upon an evaluation by testing of the purity of the in-process material? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans The question, though, I think, was specifically, if you recover the API from the expired drug product, if you’ve gone beyond the expiry date of the drug product, does that also mean that the API has expired? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans In the event of raw material supply shortfall, can the API producer reprocess or rework a raw material? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans I’m processing an API batch and one of the operators mentions to a supervisor that foreign object has fallen into the batch. Our tech ops group has evaluated the situation and feels that it could be removed by repeating a filtration step. If we are confident that there is no solubility or extractable issues, can this be considered reprocessing rather than rework? 924 viewsDrugsPharmaceutical 0 Votes 1 Ans You mentioned that reprocessing for biotech applications might require higher scrutiny than as outlined in Section 14.2. What criteria should be considered as unique to biotech applications to allow reprocessing? Is validation required prior to lot release? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans If all of the equipment in a room is dedicated to a unique operation, is it enough to label the room or should we indicate the individual status of each piece of equipment? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans The reason for non-conformance should be investigated if for a reworking, but it is not mentioned for reprocessing. Does it mean that in the case of an OOS reprocessing could be done without investigating the cause of the OOS? For example, OOS endotoxin of an intermediate could simply be resolved by reprocessing in a chromatographic step that was part of an earlier step in the process. 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans You have an API, you’ve discharged it, it passes all specifications, but it’s highly colored so you decide to repeat the crystallization. However, in repeating the crystallization, you this time add activated carbon. The inference is that activated carbon was not part of the original process and the carbon is added to remove the color bodies or impurities. Then the question goes on to ask is this rework or reprocess? The solvent remains the same. If it is a rework, is it a CBE or an annual report? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Assuming a validated process will normally contain both validated steps, critical and unvalidated steps, would it not be correct to define reprocessing in terms of the validated process? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a distinction between a validated processing step and a validated process? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans This is rather interesting, if you rework something and rework procedure becomes part of your established procedure or in other words, the rework procedure became routine, it was incorporated as part of the established procedure and it was validated. If you have to do the same rework again, would that be reprocessing? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Do your recovered materials, second crop…need specifications if there are established procedures to purify this material and this purified second crop always passes finished API specifications? 889 viewsDrugsPharmaceutical « Previous 1 2 … 55 56 57 58 59 … 79 80 Next » Question and answer is powered by anspress.net
