Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans For what deviations are OOS investigations required: in-process test monitoring, excursions outside the historical range, environmental, critical quality impeaching, intermediate impurity tests (final impurity okay)? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Under what conditions can quality typically delegate authority for releasing Intermediates to production? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans All agree for closed system environmental monitoring room classifications are not necessary. What about where a finished API is isolated and packaged? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Would the agency expect a maximum residual carry over from a previous batch to be specified and validated? What other rationale could be used for demonstrating that residual carryover does not affect final API quality? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans The section on impurities relates only to process-related impurities. Does Q7A address impurities that arise from contaminants external to the process, for example, brine inclusion into a batch from a condenser failure? If not, where is this addressed? 862 viewsDrugsPharmaceutical 0 Votes 1 Ans This one applies to chromatography fractions and if your specification is 90 to 100% for the potency, is mixing of fractions with a potency less than 90% allowed if the final potency of the blended fraction meets the not less than 90% purity requirement? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Is mixing of two or more batches of intermediate allowed, one of which might be OOS, into solution when reacting the next stage? Assume a weighted average meets the specification. 985 viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to perform homogeneity tests on two acceptable batches that have been blended into one batch? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it only required for critical steps to be witnessed or should all steps be witnessed? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 8.4 says that batches should have been tested prior to blending. Do you strongly recommend doing it prior to or is it possible for the company to take a business risk and test individual batches at the same time that blending operation is taking place? 889 viewsDrugsPharmaceutical 0 Votes 1 Ans If you blend a tailing into another batch and then retest the blended batch, if you have a policy that is based on retest dates given after the testing, then wouldn’t the blended batch get a retest clock in this case? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Can heels from dryers, and the example that’s given here is 60 kilos, be left inside the equipment between batches of the same campaign? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Is mixing a centrifuge heel material with the next batch not blending? If we don’t consider that blending, how should that be handled? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to blend second crop material with first crop material? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans I’ve got a question regarding the labeling that I discussed for materials that are subdivided in Section 8.1. For any material with hazardous specification, is Q7A in line with OSHA or other safety requirements for labeling or how does Q7A deal with the safety? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans If a validated automated warehouse is used for inventory control of materials and/or product, does this type of system provide adequate control or access to labeling material or are additional controls for separate storage areas required for printed materials? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans For packaging and labeling issues, is material transferred to and from contract manufacturers still considered control of the API parent firm? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you elaborate on your last slide in packaging stating if a container seal breach occurs or a label is missing recipient will be alerted to the possibility of contents being altered? The first question is who should do the alerting? A missing label can occur in transport and originator may not even know it. 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Is that in the GMPs? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you perform accelerated stability studies on an API to extend the retest date if running room temperature studies concurrently? And, the statement is made, “Drug product firms do this routinely, to place a two-year expiry date on the product”. 929 viewsDrugsPharmaceutical « Previous 1 2 … 46 47 48 49 50 … 79 80 Next » Question and answer is powered by anspress.net
