Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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 0 Votes 1 Ans If you are evaluating a technical change in production and the yield and/or quality are not improved or even affected, what do you do with the batches involved? Can they be sold? 971 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it required to perform an IQ to a piece of equipment that has been operating normally for a long time? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans If we have a lot of API manufactured at another parameter other than the target, but within the range, should we use or should we do an investigation? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans If one of the validation batches fail, can a company redo one more batch to the validation for three consecutive batches, need to be repeated? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Do we have to validate the mother liquor recovery process? 929 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it a requirement that analytical methods be validated prior to process validation? 1.10K viewsDrugsPharmaceutical « Previous 1 2 … 53 54 55 56 57 … 79 80 Next » Question and answer is powered by anspress.net
