Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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 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 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 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 0 Votes 1 Ans We had an FDA auditor objecting to a remilling of an API because the remilling was not included in the registration as an option. Based on the information provided here, I would understand that this is an acceptable reprocess. 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans How frequently can a rework step be performed before it is considered routine? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Do recovered solvents need to be reused/returned at the same steps from which they were recovered? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans The guideline applies to reprocessing of both conforming and non-conforming materials, what is an example of when you might reprocess in a conforming batch? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans If prior to the finished purification we add to the batch second crops from previous batches or residues from the dryer process of a previous batch, is it not blending? Is it reprocessing? So are we allowed to do this type of reprocessing? 908 viewsDrugsPharmaceutical 0 Votes 1 Ans Does material reprocessed by the filed process get a new manufacturing date under Q7A? There is a school of thought that understands original manufacturing date must be kept. 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Reference standards are extensively characterized in house. When we send these standards to our contract manufacturer, what tests should they conduct on the material received? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Under QA responsibilities not to be delegated, approval of contract manufacturers was listed. The question is, what does this mean? What specific responsibilities does QA have to approve a contract manufacturer? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans For contract manufacturing, is an audit required if the firm has on-site representatives during all the manufacturing at the contractor’s site? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it all right to use contract warehouse space for storage of APIs? 1.23K viewsDrugsPharmaceutical « Previous 1 2 … 56 57 58 59 60 … 79 80 Next » Question and answer is powered by anspress.net
