Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 947 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? 1.26K 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? 1.11K 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? 954 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? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address the traceability of reprocessed/reworked batches? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans I believe that the ICH guideline on stability and the FDA guideline on stability have said, upon retest, the material should be used immediately, something to this effect. I believe this contradicts the Q7A intent and I think the whole industry intent. 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans In order to use reprocessing at retest date, what type of provision, if any, must be in the NDA? What must be done in the NDA or supplement to allow rework? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans When we do a retest for customers, they frequently ask why we can’t re-start the shelf life? After some explanation, they accept why, but then they ask the question, how long can we keep the raw material before it must be consumed? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans If, as you say, material can be reprocessed at its retest date, what new retest date should be given to the reprocessed API? If retest is five years, can you reprocess at five years, then wait another five years to the next retest date? 865 viewsDrugsPharmaceutical 0 Votes 1 Ans Some drums of an API were in a room next to a smoky fire. There’s no visible damage to the inner packaging, although the outer drums were sooty. 211 specifies that the drug product would need to be destroyed. What would the recommendation be with respect to the intent of Q7A in destruction or reprocessing? The material still meets the established specifications. 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a limit to the number of times a given batch of API can be reprocessed? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans How should rework/reprocess be addressed for products still in clinical phase where no license yet exists to permit these activities? 885 viewsDrugsPharmaceutical 0 Votes 1 Ans If the reprocessing step is not in the filing, can the product be sold on the U.S. market, assuming that the reprocessing procedure is validated? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans How often should SOPs and policies be reviewed? Is there a maximum time limit? For example, one, two, three, four, five years? 1.14K viewsDrugsPharmaceutical « Previous 1 2 … 54 55 56 57 58 … 79 80 Next » Question and answer is powered by anspress.net
