Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Why would it not be acceptable to blend two batches of material, one with a high concentration with one with a low or out-of-spec concentration, if the reason for the low concentration is understood and the batch has no quality-related defects? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans When you discussed blending and identified process steps that were not blending steps, are you suggesting that the not blending steps are simply part of the normal process? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans In a continuous process involving several purification steps, must all the intermediates be released prior to going into the next step provided each step has its own protocol and article number and that the process consists of a series of those steps? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans If centrifuge loads are not blended when they are combined, is it necessary to evaluate centrifuge load uniformity during process validation, i.e., first, fifth, tenth load? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible to blend some different OOS batches to have a sufficient quantity of products to perform reworking or reprocessing? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans On production and process controls, if carry over from batch to batch is allowed, how would you address an issue of raw material related recall? 875 viewsDrugsPharmaceutical 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 « Previous 1 2 … 46 47 48 49 50 … 82 83 Next » Question and answer is powered by anspress.net
