Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 941 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? 824 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? 969 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? 928 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it a requirement that analytical methods be validated prior to process validation? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it recommended to qualify analytical equipment used in QC/QA labs that don’t perform methods validation if the QC/QA lab used calibrated equipment and performed systems suitability at time of use? 946 viewsDrugsPharmaceutical 0 Votes 1 Ans One could argue that a computer system used for process control and process automation is equipment and therefore subject qualification and not validation. Can you comment on this? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans For submission of the PAI, FDA needs one batch produced or one validation batch, can a demo batch be acceptable for that if a validation protocol already exists for future commercial campaigns? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it allowable to recover, and presumably use, API from expired drug product and, if so, what data is involved? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans A rework can be beyond the filing process. Our current expectation is to update the filing for the rework process prior to release. To update the filing, we must validate the rework, requiring multiple runs. How does this correlate with the Q7A GMP expectation of no validation required and only run one run? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you reprocess expired API? 908 viewsDrugsPharmaceutical 0 Votes 1 Ans If in-process non conformance results are not documented as such prior to continuing the process, how will you know that a change is indeed required in the process? How many chances at reprocessing do you get to conform to specs prior to rejection of the lot? 951 viewsDrugsPharmaceutical 0 Votes 1 Ans For a reused container, does the documented cleaning procedure need to be validated? Is there an expectation of a monitoring program for solvents stored in bulk, and the frequency thereof? Is there any expectation for the monitoring of critical parameters using continuous chart recorders or two manual operator documentation of a specific time period? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by additional analytical methods under rework? Shouldn’t you already know what your methods are? Is it appropriate to create new methods for a process just because it is reworked material? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans It is understandable that you cannot validate a single rework, so why shouldn’t Q7A be stronger regarding the need to do more intensive testing, including stability testing, on reworked batches? For reworked batches, are stability studies necessary; what instances would require stability studies? 1.19K viewsDrugsPharmaceutical « Previous 1 2 … 235 236 237 238 239 … 283 284 Next » Question and answer is powered by anspress.net
