Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.33K 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? 888 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between designating reprocessing versus rework? If the difference is nil, than why is it so important to make this distinction between reprocessing versus rework? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What is required in order for the manufacturer to be able to do the rework and sell the batch? For example, validation protocol, prior approval from FDA, annual report filing, supplement, etc.? 915 viewsDrugsPharmaceutical 0 Votes 1 Ans If an API is returned by a customer for non-quality reasons, example, inventory levels, etc., and the customer sends documentation stating that the API was handled to GMP, could the API be resold without reprocessing? 896 viewsDrugsPharmaceutical 0 Votes 1 Ans Are complaint records required between different sites/operations of a single company, i.e. a drug product manufacturer at Site A and the API supplier at Site B? And, I will take this one step further. The API supplier actually might have two facilities that feed that drug product situation, because a lot of us have that situation in our plants. So, basically, the question becomes, where should the complaint records be kept and what are required. 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans If during a reprocessing, two lots are dissolved prior to crystallization and one has an unknown impurity level, can a reprocessed lot be reprocessed, dissolved, crystallized to remove the impurity, provided that the impurity is a common one for the product? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans For batches reprocessed or reworked because of non-conformance, do all analytical tests need to be performed again? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to reprocess non-conforming batches without an investigation? This presentation implies that investigation is only expected for batches to be reworked. Does reprocessing that involves a critical step need to be validated? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Why does Q7A not prohibit the use of recovered solvents from process A or process B? What is absence of process impurities? Not detected does not seem to be reasonable acceptance criteria. Not detected is up to what level of accuracy? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you reprocess or rework the same material more than one time? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Please comment about minimum testing requirements for returned material that will be reworked. What will be the minimum testing requirements before reworking? 1.26K viewsDrugsPharmaceutical « Previous 1 2 … 237 238 239 240 241 … 283 284 Next » Question and answer is powered by anspress.net
