Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.53K 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? 1.79K 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? 1.54K 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? 1.64K 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? 1.53K 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? 1.60K 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? 1.67K 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? 1.59K 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? 1.56K 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? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans What does “appropriate testing of each chemical batch before blending” mean? 1.40K 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? 1.65K 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. 1.49K 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? 1.59K 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? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans How are OOS results in yields dealt with at process start-up for a new campaign? Specifically, how should atypical results be dealt with when they are due to hold ups or…in the initial batch at start-up? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Relative to Section 8.2 on time limits, does stability of a batch under certain processing conditions need to be established by laboratory studies or historical processing data in order not to have to specify time limits? Do max hold times need to be established based on historical data or laboratory stability studies? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans What, if any, stability is expected to be performed on intermediates processed in house? A side question on that is it expected to have retest dates for intermediates that do not leave the company? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Please comment on holding times for intermediates or APIs and the difference between holding times and time limits. 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans The other part of the question was, comment on holding times for intermediates or APIs. 1.43K viewsDrugsPharmaceutical « Previous 1 2 3 4 … 79 80 Next » Question and answer is powered by anspress.net
