Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.65K 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? 1.51K 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. 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans For a critical process parameter, what is the appropriate method of monitoring, continuous or manual? 1.75K 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? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans For what deviations are OOS investigations required: in-process test monitoring, excursions outside the historical range, environmental, critical quality impeaching, intermediate impurity tests (final impurity okay)? 1.40K 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? 1.37K 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.? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to sample raw materials in a controlled environment? 1.46K 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? 1.55K 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? 1.64K 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? 1.47K 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? 1.49K 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? 1.64K 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? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans For yields and ranges, how do you define appropriate ranges for yield, the percentages? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans If the yield and the quality of an API improved drastically over time without explanation, to what extent should it be investigated? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Would the agency expect you to adjust your ranges to include the new values? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans There is no expectation in Q7A to have to audit starting material suppliers. It was also stated that starting material suppliers should be qualified. Does this mean that vendor qualification does not need to include an audit? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans If Q7A does not apply to API starting materials, is it necessary or mandatory to, first of all, audit manufacturers of API starting materials? And B, if an API manufacturer decides to audit the manufacturers starting materials, against which document should the audit be conducted? 1.27K viewsDrugsPharmaceutical « Previous 1 2 3 4 5 … 79 80 Next » Question and answer is powered by anspress.net
