Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is it necessary to validate the process in the manufacture of an intermediate? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans May Equipment qualification and equipment validation be used interchangeably to mean the same thing? 992 viewsDrugsPharmaceutical 0 Votes 1 Ans For the cleaning of dedicated equipment in a facility dedicated to the manufacture of a single API, is visibly clean an acceptable criterion for cleaning validation, i.e., no requirement for specific determination of the API? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans In general, do in-process test methods need to be validated? 1.14K viewsDrugsPharmaceutical 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? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Please explain why combining several centrifuge loads from a batch is not considered blending in Q7a. 1.06K 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? 963 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to validate at a scale less than that of the commercial process (e.g., 10%)? 1.27K 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? 1.28K 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? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans To add on to that, could there be steps filed that are not critical? 951 viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address the need for PQ in new pilot-scale equipment prior to validation? 901 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? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Also, does the reprocess of non-conforming material require an investigation? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a reprocess of non-conforming material require validation? 1.18K 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? 1.05K 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? 908 viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding Q7A, is there a need to validate in process analytical tests that are used to monitor reaction progress? 1.23K 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? 1.33K 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? 1.22K viewsDrugsPharmaceutical « Previous 1 2 … 233 234 235 236 237 … 283 284 Next » Question and answer is powered by anspress.net
