Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 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? 1.87K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it only required for critical steps to be witnessed or should all steps be witnessed? 1.84K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to perform homogeneity tests on two acceptable batches that have been blended into one batch? 1.80K 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. 1.69K 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? 1.96K 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? 1.67K 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? 1.97K 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? 1.68K 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? 1.77K 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? 1.65K 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? 1.75K 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? 1.78K 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? 1.73K viewsDrugsPharmaceutical 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? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans If we’re at a step where we can get a good feel for the final quality of the batch, the last step before concentration and drying, we know that the batch will not pass release testing, we could conceivably mix this batch with another superior quality batch so that in the final step, the final material will pass. Would this be considered blending an OOS batch? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans What does “appropriate testing of each chemical batch before blending” mean? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans If a batch is broken into several fractions and then recombined, is it necessary for all the individual fractions to pass the final in-process specification? 1.78K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between combining fractions from several batches for further processing, which is an activity not considered blending, and blending of tailings from batches of the same intermediate or API, which is considered blending. Please clarify it. 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans If you combine two crystallized batches for drying, do you have to test the wet material against the full specification? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there any limitation for the lot size of a blended lot based on the Q7A? For example, the lot size should not exceed the capacity of the blender? 1.75K viewsDrugsPharmaceutical « Previous 1 2 3 4 … 82 83 Next » Question and answer is powered by anspress.net
