Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Q7A is titled “Good Manufacturing Guidance for Active Pharmaceutical Ingredients”. Why does it not include the reference to “current” as in 21 CFR 211? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Please explain why combining several centrifuge loads from a batch is not considered blending in Q7a. 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans How is blending of small batches to increase batch size different from combining fractions from several batches of intermediate for further processing? 919 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to validate at a scale less than that of the commercial process (e.g., 10%)? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Please discuss re-validation as it relates to scale-up. If the same equipment is used, is there any restriction on how much the scale can be increased prior to re-validation? If similar but different equipment were used, would re-validation be required? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans A batch of new API is produced prior to validation. Can this batch be used for commercial distribution after completion of validation of the API process? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans To add on to that, could there be steps filed that are not critical? 903 viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address the need for PQ in new pilot-scale equipment prior to validation? 855 viewsDrugsPharmaceutical 0 Votes 1 Ans In defining the critical process steps to be validated, are there ways that you have seen companies avoid the analysis paralysis of reasoning that all steps could be critical and therefore seek to validate all steps? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Also, does the reprocess of non-conforming material require an investigation? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a reprocess of non-conforming material require validation? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a need to define environmental control specification for API processing area and powder handling area such as particle…micro-biological and so on? 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans During clinical trials, is it acceptable to transfer the analytical methods to quality control for conducting of stability testing and for release testing prior to final validation of the method being completed? Does analytical need to continue the routine executing of the method until final validation? 864 viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding Q7A, is there a need to validate in process analytical tests that are used to monitor reaction progress? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to validate drying using an LOD spec target without regard to drying time? If so, does this mean significant time differences between batches would not be considered deviations? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans In the case of a contract manufacturer producing an API for a client abroad, must the process be validated entirely by the contractor or can it be partly done by both parties? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans You have a validated process. Do we need to disqualify a previous process validation and repeat the process validation after product failures? 924 viewsDrugsPharmaceutical 0 Votes 1 Ans Would a clean-up procedure be considered critical, and then, therefore, it would have to be validated. 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to investigate yield discrepancies not associated with critical process steps? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans If the theoretical yield of a synthetic process is 20 kilograms, is that the batch size or if the typical yield is 16 to 17 kilograms, is that the batch size? On your batch record, what do you call the batch size? The yield or what gets charged or the amount of starting material? 1.08K viewsDrugsPharmaceutical « Previous 1 2 … 52 53 54 55 56 … 82 83 Next » Question and answer is powered by anspress.net
