Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does three-batch testing of raw material have to include all tests listed on the supplier Certificate of Analysis? If your company’s specifications do not include all of those listed by the supplier, would it be acceptable to test to you specifications? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Do distributors of raw materials need to be approved and put on an approved supplier list? What is needed? Is an audit needed? 999 viewsDrugsPharmaceutical 0 Votes 1 Ans Section 8.3 regarding OOS. For example, the illustration, your target was to drive to an LOD of 2%, and after a number of hours, the LOD is at 2.5%. Further drying cannot drive the LOD lower than 2.5. Shall the 2.5% be considered as OOS? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans For a critical process parameter, what is the appropriate method of monitoring, continuous or manual? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans How does Q7A deal with the addition of seed crystals to induce crystallization with respect to: amount of seed needed and used, type, i.e. particle size distribution of seed material, and documentation. 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans What if a step has no specified time limit in the master production record, but you have an unexplained process delay? While waiting to make a solvent change, if you know that there’s no quality impact, then what sort of deviation or documentation would be expected? 858 viewsDrugsPharmaceutical 0 Votes 1 Ans If we have other ways to measure the process (e.g. temperature, in process tests, pH, etc), do we have to specify a time limit? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Please comment on holding times for intermediates or APIs and the difference between holding times and time limits. 1.26K 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? 1.25K 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? 992 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? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Would the agency expect you to adjust your ranges to include the new values? 850 viewsDrugsPharmaceutical 0 Votes 1 Ans If the yield and the quality of an API improved drastically over time without explanation, to what extent should it be investigated? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans For yields and ranges, how do you define appropriate ranges for yield, the percentages? 1.17K 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? 931 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? 1.02K 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. 1.14K 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? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What does “appropriate testing of each chemical batch before blending” mean? 1.05K 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? 1.14K viewsDrugsPharmaceutical « Previous 1 2 … 45 46 47 48 49 … 82 83 Next » Question and answer is powered by anspress.net
