Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans When and where do we start applying CGMPs? For example, we may use isopropanol to make the reaction of our API or to purify API. We do not manufacture isopropanol, so does the manufacturer of isopropanol have to follow all the CGMPs that apply to us? Does the manufacturer of any excipient have to follow the CGMPs as we do? 1.13K viewsDrugsPharmaceutical 0 Votes 2 Ans If the conductivity is 1.31 microSiemens per cm at 25C is it out of specs already; USP says 1.3 microSieat 25C 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the second review of a critical processing step need to take place at the time the step is performed? Does the supervisor review following the unit operation meet this requirement? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans If the QC laboratory releases the bulk of the raw material and then the material is subdivided, does QC have to release it again? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans In Europe, it is common to require only a single signature for critical manufacturing steps. In the batch records, Q7A requires a second person to verify. Which system will prevail in Europe? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Are detailed recipes on the PLC level seen as part of the master instructions? If yes, is review and approval required? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Prior to issuing for use, batch production records should be reviewed, dated and signed to prove that it’s the correct version. Can the production department perform this check or does QA need to do it? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Storage conditions are listed on raw materials for reasons unrelated to GMP, i.e., some solvents are listed at store below 72°F to avoid high vapor pressures that could cause spills upon opening. How might non-GMP-related conditions be delineated to avoid inspector confusion? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to sample raw materials in a controlled environment? 830 viewsDrugsPharmaceutical 0 Votes 1 Ans By full analysis on batches of raw material in order to qualify a vendor, does this mean all the analysis reported on the vendor’s C-of-A or just the analysis we deem critical, i.e. assay, melting point, water, etc.? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans You mentioned accepting starting materials by performing an ID test in accepting the Certificate of Analysis from a qualified supplier. Could you elaborate on expectations regarding full and reduced testing? 990 viewsDrugsPharmaceutical 0 Votes 1 Ans Are we expected to QC release polybags, drums and containers and plastic scoops used to scoop and sample APIs? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans May raw materials delivered in tankers be mixed in silos with old batches of the very same raw material after a limited ID testing is performed? Date and time of mixing and identity are, of course, well known. 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Does three-batch testing of raw material have to include all tests listed on the supplier Certificate of Analysis? If your company’s specifications do not include all of those listed by the supplier, would it be acceptable to test to you specifications? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Do distributors of raw materials need to be approved and put on an approved supplier list? What is needed? Is an audit needed? 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 8.3 regarding OOS. For example, the illustration, your target was to drive to an LOD of 2%, and after a number of hours, the LOD is at 2.5%. Further drying cannot drive the LOD lower than 2.5. Shall the 2.5% be considered as OOS? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans For a critical process parameter, what is the appropriate method of monitoring, continuous or manual? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans How does Q7A deal with the addition of seed crystals to induce crystallization with respect to: amount of seed needed and used, type, i.e. particle size distribution of seed material, and documentation. 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans What if a step has no specified time limit in the master production record, but you have an unexplained process delay? While waiting to make a solvent change, if you know that there’s no quality impact, then what sort of deviation or documentation would be expected? 858 viewsDrugsPharmaceutical 0 Votes 1 Ans If we have other ways to measure the process (e.g. temperature, in process tests, pH, etc), do we have to specify a time limit? 1.24K viewsDrugsPharmaceutical « Previous 1 2 … 44 45 46 47 48 … 79 80 Next » Question and answer is powered by anspress.net
