Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 926 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? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Should process validation be performed at full production scale or can it be performed at one-third or one-tenth commercial scale? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the ranges for expected yield be set post approval with biotech products where as little as three to four API batches at scale may have been produced and historical data sets will be very small? 930 viewsDrugsPharmaceutical 0 Votes 1 Ans Please elaborate more between concurrent and prospective validation. Is it only related with final release of the batches for commercial use? And question two, do we need to specifically include the batch number on validation protocol or specifying number of batches is enough? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans In a new facility, can you start process validation prior to completion of water system validation that will run for several months to a year? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Is your process validation starting point defined of your choice of your API starting material? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Why was steaming sterilization validation not included in the guidelines? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans You’ve done your qualifications, you’ve calibrated all of your equipment, now you’ve done your batches, and do you have to do immediate post-calibration of the instrumentation? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans When you perform a process validation, should the equipment instruments be calibrated immediately after the completion of the validation runs? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans You’ve done your qualifications, you’ve calibrated all of your equipment, now you’ve done your batches, and do you have to do immediate post-calibration of the instrumentation? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the expectation on performing process validation without the qualification or validation of utilities that are in contact with the product? Examples, steam, nitrogen. 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans If, during a process chemical validation, one validation batch fails due to an assignable cause, equipment malfunction, how many validation batches are necessary to demonstrate consistency and/or to complete the validation, one more lot or three more consecutive lots? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans If a reaction temperature ranges from 60 to 70, do you run validation batches at 60, 65 and 70 or three at 65? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Are firms expected to have a product development report to identify the critical steps and critical parameters of the process to yield an acceptable product and limit impurities? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans If a company dries to an LOD specification, doesn’t that imply the drying process is not validated? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a process step be defined as small as a single instruction in a batch record? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans When should customers be notified of change? Before or after implementation? 1.30K viewsDrugsPharmaceutical « Previous 1 2 … 234 235 236 237 238 … 283 284 Next » Question and answer is powered by anspress.net
