Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 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? 926 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? 1.21K 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? 1.12K 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? 1.23K 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? 1.20K 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. 1.06K 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? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans When should customers be notified of change? Before or after implementation? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding the requirement that first batches have to be evaluated after a change, is this for every change or just major changes? For instance, a change in wording for clarity in manufacturing batch instructions would need evaluation? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans If a part or a piece of equipment fails and is replaced by a functionally equivalent, but not identical part, will this be classified as a change? For example exchange of 304 versus 316 stainless steel construction. 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans If an API process is confidential and is described in a master file, how should the API producer deal with informing customers of a process change? 943 viewsDrugsPharmaceutical 0 Votes 1 Ans If the quality unit is required to approve changes that impact product quality, who decides if a change impacts the product quality? 825 viewsDrugsPharmaceutical « Previous 1 2 … 53 54 55 56 57 … 82 83 Next » Question and answer is powered by anspress.net
