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? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans May Equipment qualification and equipment validation be used interchangeably to mean the same thing? 1.04K 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? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans In general, do in-process test methods need to be validated? 1.18K 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? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Please explain why combining several centrifuge loads from a batch is not considered blending in Q7a. 1.10K 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? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to validate at a scale less than that of the commercial process (e.g., 10%)? 1.32K 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? 1.33K 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? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans To add on to that, could there be steps filed that are not critical? 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address the need for PQ in new pilot-scale equipment prior to validation? 947 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? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Also, does the reprocess of non-conforming material require an investigation? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a reprocess of non-conforming material require validation? 1.23K 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? 1.10K 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? 955 viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding Q7A, is there a need to validate in process analytical tests that are used to monitor reaction progress? 1.28K 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? 1.38K 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? 1.28K viewsDrugsPharmaceutical « Previous 1 2 … 233 234 235 236 237 … 283 284 Next » Question and answer is powered by anspress.net
